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Abbott Laboratories, Inc
Abbott Laboratories, Inc: 32 FDA recall reports
Every medical device recall the FDA has published for Abbott Laboratories, Inc. The fault, and how the agency graded it.
32Reports
0Class I
2Ongoing
2022-03-23Most recent
What the classes mean
The FDA sorts every recall into one of three classes. The class is the whole story. It is also the part people skip.
Class II is the bulk of every list here. That matters. A long list of Class II says something different from one Class I.
By class
By year reported
Checking whether it affects you
The lot or code number is what matters. Not the product name. A recall covers
specific lots. Yours may not be one of them.
Check the code on your package against the report. The FDA keeps the current
list at fda.gov/safety/recalls.
The reports
The text below is quoted from the FDA record word for word.
Alinity s System software version2.8.0, REF LN 06P16-01, IVD, OEI: (01)00380740138479 The Alinity s System
Z-0749-2022 · Class II · reported 2022-03-23 · Ongoing
- Why it was recalled
- Software error associated with the immunoassay analyzer wash cycle which is using 1 mL of wash buffer instead of the intended 3 mL of wash buffer to wash the exterior of the probe.
- Product
- Alinity s System software version2.8.0, REF LN 06P16-01, IVD, OEI: (01)00380740138479 The Alinity s System is intended for In Vitro diagnostic use only. The Alinity s System is a highthroughput, fully automated immunoassay analyzer designed to determine the presence of specific antigens and antibodies by using chemiluminescent immunoassay technology.
- Where it went
- Worldwide distribution: US (nationwide) including states of: AL, CA, GA, IL, IN, MN, MO, NC, OK, PA, RI, SC, TN, TX, WA, WI, MD and countries (OUS) including of: Australia, Austria, Bahrain, Belgium, Brazil, china, Colombia, Croatia, Cyprus, Czech Republic, Egypt, Germany, Greece, Hong Kong, Hungary, Iran, Ireland, Israel, Italy, Jordan Kuwait and Mexico.
- How much
- 306 units
Alinity s System REF 06P16-01. An automated immunoassay analyzer for In Vitro diagnostic use in blood donor
Z-2276-2021 · Class II · reported 2021-08-18 · Ongoing
- Why it was recalled
- A design defect (hardware and software) allows liquid waste pressure to build up and potentially spray users/operators.
- Product
- Alinity s System REF 06P16-01. An automated immunoassay analyzer for In Vitro diagnostic use in blood donor screening, plasma and plasmapheresis screening, and organ donor centers, hospitals, and reference laboratories.
- Where it went
- Worldwide distribution. US nationwide, Australia, Bahrain, Belgium, Brazil, China, Colombia, Croatia, Egypt, Germany, Greece, Hong Kong, Hungary, Iran, Ireland, Israel, Italy, Jordan, Kuwait, Mexico, Netherlands, Pakistan, Poland, Portugal, Saudi Arabia, Serbia, Slovenia, South Africa, Spain, Tanzania, United Arab Emirates, United Kingdom, Ukraine and Zimbabwe.
- How much
- 260 systems
ARCHITECT C System Mixer - Product Usage: The ARCHITECT Clinical Chemistry System is designed to perform autom
Z-1671-2020 · Class II · reported 2020-04-15 · Terminated
- Why it was recalled
- Mixer blade may separate from mixer due to the screw and nut failure and detachment. As a result of the mixer blade missing, the sample and reagent are inadequately mixed.
- Product
- ARCHITECT C System Mixer - Product Usage: The ARCHITECT Clinical Chemistry System is designed to perform automated chemistry tests, utilizing photometry and potentiometric technology. The mixer is a component and it is used on all ARCHITECT Clinical Chemistry systems to mix the sample with the reagent inside of the cuvettes.
- Where it went
- Worldwide distribution US Nationwide distribution in the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, ME, MN, MO, MS, MT, NC, ND, NE, NJ, NM, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA, WI, Puerto Rico and St. Croix US Virgin Islands. Countries of AF, AL, AO, AR, AM, AU, AT, AZ, BS, BD, BV, BE, BA, BW, BR, BN, BG, BF, CA, CL, CN, CO, CR, HR, CY, CZ, CD, DK, DO, EC, EG, SV, EE, ET, FI, FR, GE, DE, GR, GT, HN, HK, HU, IN, ID, IQ, IE, IL, IT, JM, JO, KZ, KE, KW, KG, LV, LB, LY, LT, LU, MK, MW, MY, MV, ML, MR, MX, MD, MA, MM, NA, NL, NZ, NG, NO, OM, PK, PA, PE, PH, PL, PT, PY, QA, RO, RU, RW, SA, SN, SG, SK, SI, ZA, ES, SE, CH, TW, TJ, TZ, TH, TT, TN, TC, TR, AE, UG, UK, UA, UY, VE, VN, YE, ZM, ZW, LC, MS, ME, VC, LK, RS, KY, CW, GZA, JRH, CI, KR.
- How much
- 09D59-01, 1010 products, 09D59-02, 25156 products, 09D59-03 13976 products
APS Accelerator modular systems, 208-230 V-, 50/60 Hz, 1800 VA, IVD, RX, Class 2 Laser Product,
Z-2755-2019 · Class II · reported 2019-10-02 · Terminated
- Why it was recalled
- The firm identified customer sites where modules which the safety pacemaker label is missing. Information regarding the label included in the Operations Manual has been updated to specify: 1) the risk of malfunction applies to anyone with a pacemaker who may work on these modules; 2) the minimum safety distance has increased to 200 mm (7.87") from transport mechanisms. Any person with a pacemaker must not get closer than this distance from modules axes.
- Product
- APS Accelerator modular systems, 208-230 V-, 50/60 Hz, 1800 VA, IVD, RX, Class 2 Laser Product,
- Where it went
- US: TX, VA, AZ, NV, MA, LA, MN, PA, SC, NJ, NY, CA, IL, IN, WA, FL, TN, PA, KS, ND, NC, CT OUS: Argentina, Australia, Belgium, Canada, China, Denmark, France, Greece, Hong Kong, Ireland, Italy, New Zealand, Norway, Oman, Pakistan, Philippines, Portugal, Russia, Saudi Arabia, Singapore, Spain, Taiwan, Turkey, UAE, UK, Venezuela
- How much
- 159 devices
C4 is an in vitro diagnostic assay for the quantitative determination of C4 in human serum or plasma. Antigen
Z-1992-2019 · Class II · reported 2019-07-31 · Terminated
- Why it was recalled
- An update to the Reagents and Specimen Collection and Handling/Preparation for Analysis sections of the IFU was required due to different issues with the various products.
- Product
- C4 is an in vitro diagnostic assay for the quantitative determination of C4 in human serum or plasma. Antigen in the sample bonds to the specific antibody in the reagent, forming an immune complex. The immune complex causes an increase in light scattering, measured by reading turbidity at 604 nm, which correlates with the concentration of C4 in the sample.
- Where it went
- Distribution was nationwide, including Puerto Rico. There was government/military distribution. Foreign distribution was made to Canada, Albania, Algeria, Andorra, Argentina, Armenia, Australia, Austria, Azerbaijan, Bangladesh, Belarus, Belgium, Bolivia, Bosnia and Herzegovi, Botswana, Brazil, Brunei, Bulgaria, Chile, China, Costa Rica, Croatia, Curacao (Netherlands Antilles), Cyprus, Czech Republic, Democratic Republic of the Congo, Denmark, Ecuador, Egypt, Estonia, Finland, France, Gaza & Jericho, Germany, Greece, Greenland, Honduras, Hong Kong, India, Iraq, Ireland, Israel, Italy, Ivory Coast, Jamaica, Jordan, Kazakhstan, Kenya, Kuwait, Kyrgyzstan, Latvia, Lebanon, Libya. Lithuania, Luxembourg, Macedonia, Malaysia, Maldives, Mali, Mauritania, Mexico, Moldova, Montenegro, Morocco, Namibia, Netherlands, New Zealand, Norway, Oman, Pakistan, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Republic of Yemen, Romania, Russia, Rwanda, Saudi Arabia, Senegal, Serbia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Tanzania, Thailand, Trinidad & Tobago, Tunisia, Turkey, Turks and Caicos, Tunisia, UAE, United Kingdom,...
- How much
- 8,037 kits
Immunoglobulin M is an in vitro diagnostic assay for the quantitative determination of immunoglobulin M in hu
Z-1990-2019 · Class II · reported 2019-07-31 · Terminated
- Why it was recalled
- An update to the Reagents and Specimen Collection and Handling/Preparation for Analysis sections of the IFU was required due to different issues with the various products.
- Product
- Immunoglobulin M is an in vitro diagnostic assay for the quantitative determination of immunoglobulin M in human serum or plasma. Antigen in the sample bonds to the specific antibody in the reagent, forming an immune complex. The immune complex causes an increase in light scattering, measured by reading turbidity at 700 nm, which correlates with the concentration of immunoglobulin M in the sample.
- Where it went
- Distribution was nationwide, including Puerto Rico. There was government/military distribution. Foreign distribution was made to Canada, Albania, Algeria, Andorra, Argentina, Armenia, Australia, Austria, Azerbaijan, Bangladesh, Belarus, Belgium, Bolivia, Bosnia and Herzegovi, Botswana, Brazil, Brunei, Bulgaria, Chile, China, Costa Rica, Croatia, Curacao (Netherlands Antilles), Cyprus, Czech Republic, Democratic Republic of the Congo, Denmark, Ecuador, Egypt, Estonia, Finland, France, Gaza & Jericho, Germany, Greece, Greenland, Honduras, Hong Kong, India, Iraq, Ireland, Israel, Italy, Ivory Coast, Jamaica, Jordan, Kazakhstan, Kenya, Kuwait, Kyrgyzstan, Latvia, Lebanon, Libya. Lithuania, Luxembourg, Macedonia, Malaysia, Maldives, Mali, Mauritania, Mexico, Moldova, Montenegro, Morocco, Namibia, Netherlands, New Zealand, Norway, Oman, Pakistan, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Republic of Yemen, Romania, Russia, Rwanda, Saudi Arabia, Senegal, Serbia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Tanzania, Thailand, Trinidad & Tobago, Tunisia, Turkey, Turks and Caicos, Tunisia, UAE, United Kingdom,...
- How much
- 9,586 kits
Apolipoprotein A1 is an in vitro diagnostic assay for the quantitative determination of apolipoprotein A1 in
Z-1991-2019 · Class II · reported 2019-07-31 · Terminated
- Why it was recalled
- An update to the Reagents and Specimen Collection and Handling/Preparation for Analysis sections of the IFU was required due to different issues with the various products.
- Product
- Apolipoprotein A1 is an in vitro diagnostic assay for the quantitative determination of apolipoprotein A1 in human serum or plasma. Antibodies to apolipoprotein A1 combine with apolipoprotein A1 in the sample to form insoluble immune complexes. The immune complexes cause an increase in light scattering (turbidity). The resulting increase in sample turbidity, measured at 804 nm, is directly proportional to the concentration of apolipoprotein A1 in the sample.
- Where it went
- Distribution was nationwide, including Puerto Rico. There was government/military distribution. Foreign distribution was made to Canada, Albania, Algeria, Andorra, Argentina, Armenia, Australia, Austria, Azerbaijan, Bangladesh, Belarus, Belgium, Bolivia, Bosnia and Herzegovi, Botswana, Brazil, Brunei, Bulgaria, Chile, China, Costa Rica, Croatia, Curacao (Netherlands Antilles), Cyprus, Czech Republic, Democratic Republic of the Congo, Denmark, Ecuador, Egypt, Estonia, Finland, France, Gaza & Jericho, Germany, Greece, Greenland, Honduras, Hong Kong, India, Iraq, Ireland, Israel, Italy, Ivory Coast, Jamaica, Jordan, Kazakhstan, Kenya, Kuwait, Kyrgyzstan, Latvia, Lebanon, Libya. Lithuania, Luxembourg, Macedonia, Malaysia, Maldives, Mali, Mauritania, Mexico, Moldova, Montenegro, Morocco, Namibia, Netherlands, New Zealand, Norway, Oman, Pakistan, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Republic of Yemen, Romania, Russia, Rwanda, Saudi Arabia, Senegal, Serbia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Tanzania, Thailand, Trinidad & Tobago, Tunisia, Turkey, Turks and Caicos, Tunisia, UAE, United Kingdom,...
- How much
- 2,112 kits
Immunoglobulin A is an in vitro diagnostic assay for the quantitative determination of immunoglobulin A in hu
Z-1988-2019 · Class II · reported 2019-07-31 · Terminated
- Why it was recalled
- An update to the Reagents and Specimen Collection and Handling/Preparation for Analysis sections of the IFU was required due to different issues with the various products.
- Product
- Immunoglobulin A is an in vitro diagnostic assay for the quantitative determination of immunoglobulin A in human serum or plasma. Antigen in the sample bonds to the specific antibody in the reagent, forming an immune complex. The immune complex causes an increase in light scattering, measured by reading turbidity at 700 nm, which correlates with the concentration of immunoglobulin A in the sample.
- Where it went
- Distribution was nationwide, including Puerto Rico. There was government/military distribution. Foreign distribution was made to Canada, Albania, Algeria, Andorra, Argentina, Armenia, Australia, Austria, Azerbaijan, Bangladesh, Belarus, Belgium, Bolivia, Bosnia and Herzegovi, Botswana, Brazil, Brunei, Bulgaria, Chile, China, Costa Rica, Croatia, Curacao (Netherlands Antilles), Cyprus, Czech Republic, Democratic Republic of the Congo, Denmark, Ecuador, Egypt, Estonia, Finland, France, Gaza & Jericho, Germany, Greece, Greenland, Honduras, Hong Kong, India, Iraq, Ireland, Israel, Italy, Ivory Coast, Jamaica, Jordan, Kazakhstan, Kenya, Kuwait, Kyrgyzstan, Latvia, Lebanon, Libya. Lithuania, Luxembourg, Macedonia, Malaysia, Maldives, Mali, Mauritania, Mexico, Moldova, Montenegro, Morocco, Namibia, Netherlands, New Zealand, Norway, Oman, Pakistan, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Republic of Yemen, Romania, Russia, Rwanda, Saudi Arabia, Senegal, Serbia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Tanzania, Thailand, Trinidad & Tobago, Tunisia, Turkey, Turks and Caicos, Tunisia, UAE, United Kingdom,...
- How much
- 12,995 kits
Immunoglobulin G is an in vitro diagnostic assay for the quantitative determination of immunoglobulin G in hu
Z-1989-2019 · Class II · reported 2019-07-31 · Terminated
- Why it was recalled
- An update to the Reagents and Specimen Collection and Handling/Preparation for Analysis sections of the IFU was required due to different issues with the various products.
- Product
- Immunoglobulin G is an in vitro diagnostic assay for the quantitative determination of immunoglobulin G in human serum or plasma. Antigen in the sample bonds to the specific antibody in the reagent, forming an immune complex. The immune complex causes an increase in light scattering, measured by reading turbidity at 700 nm, which correlates with the concentration of immunoglobulin G in the sample.
- Where it went
- Distribution was nationwide, including Puerto Rico. There was government/military distribution. Foreign distribution was made to Canada, Albania, Algeria, Andorra, Argentina, Armenia, Australia, Austria, Azerbaijan, Bangladesh, Belarus, Belgium, Bolivia, Bosnia and Herzegovi, Botswana, Brazil, Brunei, Bulgaria, Chile, China, Costa Rica, Croatia, Curacao (Netherlands Antilles), Cyprus, Czech Republic, Democratic Republic of the Congo, Denmark, Ecuador, Egypt, Estonia, Finland, France, Gaza & Jericho, Germany, Greece, Greenland, Honduras, Hong Kong, India, Iraq, Ireland, Israel, Italy, Ivory Coast, Jamaica, Jordan, Kazakhstan, Kenya, Kuwait, Kyrgyzstan, Latvia, Lebanon, Libya. Lithuania, Luxembourg, Macedonia, Malaysia, Maldives, Mali, Mauritania, Mexico, Moldova, Montenegro, Morocco, Namibia, Netherlands, New Zealand, Norway, Oman, Pakistan, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Republic of Yemen, Romania, Russia, Rwanda, Saudi Arabia, Senegal, Serbia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Tanzania, Thailand, Trinidad & Tobago, Tunisia, Turkey, Turks and Caicos, Tunisia, UAE, United Kingdom,...
- How much
- 11,063 kits
Apolipoprotein B is an in vitro diagnostic assay for the quantitative determination of apolipoprotein B in hu
Z-1994-2019 · Class II · reported 2019-07-31 · Terminated
- Why it was recalled
- An update to the Reagents and Specimen Collection and Handling/Preparation for Analysis sections of the IFU was required due to different issues with the various products.
- Product
- Apolipoprotein B is an in vitro diagnostic assay for the quantitative determination of apolipoprotein B in human serum or plasma. Antibodies to apolipoprotein B combine with apolipoprotein B in the sample to form insoluble immune complexes. The immune complexes cause an increase in light scattering (turbidity). The resulting increase in sample turbidity, measured at 604 nm, is directly proportional to the concentration of apolipoprotein B in the sample.
- Where it went
- Distribution was nationwide, including Puerto Rico. There was government/military distribution. Foreign distribution was made to Canada, Albania, Algeria, Andorra, Argentina, Armenia, Australia, Austria, Azerbaijan, Bangladesh, Belarus, Belgium, Bolivia, Bosnia and Herzegovi, Botswana, Brazil, Brunei, Bulgaria, Chile, China, Costa Rica, Croatia, Curacao (Netherlands Antilles), Cyprus, Czech Republic, Democratic Republic of the Congo, Denmark, Ecuador, Egypt, Estonia, Finland, France, Gaza & Jericho, Germany, Greece, Greenland, Honduras, Hong Kong, India, Iraq, Ireland, Israel, Italy, Ivory Coast, Jamaica, Jordan, Kazakhstan, Kenya, Kuwait, Kyrgyzstan, Latvia, Lebanon, Libya. Lithuania, Luxembourg, Macedonia, Malaysia, Maldives, Mali, Mauritania, Mexico, Moldova, Montenegro, Morocco, Namibia, Netherlands, New Zealand, Norway, Oman, Pakistan, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Republic of Yemen, Romania, Russia, Rwanda, Saudi Arabia, Senegal, Serbia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Tanzania, Thailand, Trinidad & Tobago, Tunisia, Turkey, Turks and Caicos, Tunisia, UAE, United Kingdom,...
- How much
- 2,273 kits
Transferrin is an in vitro diagnostic assay for the quantitative determination of transferrin in human seru
Z-1995-2019 · Class II · reported 2019-07-31 · Terminated
- Why it was recalled
- An update to the Reagents and Specimen Collection and Handling/Preparation for Analysis sections of the IFU was required due to different issues with the various products.
- Product
- Transferrin is an in vitro diagnostic assay for the quantitative determination of transferrin in human serum or plasma. Antigen in the sample bonds to the specific antibody in the reagent, forming an immune complex. The immune complex causes an increase in light scattering, measured by reading turbidity at 700 nm, which correlates with the concentration of transferrin in the sample.
- Where it went
- Distribution was nationwide, including Puerto Rico. There was government/military distribution. Foreign distribution was made to Canada, Albania, Algeria, Andorra, Argentina, Armenia, Australia, Austria, Azerbaijan, Bangladesh, Belarus, Belgium, Bolivia, Bosnia and Herzegovi, Botswana, Brazil, Brunei, Bulgaria, Chile, China, Costa Rica, Croatia, Curacao (Netherlands Antilles), Cyprus, Czech Republic, Democratic Republic of the Congo, Denmark, Ecuador, Egypt, Estonia, Finland, France, Gaza & Jericho, Germany, Greece, Greenland, Honduras, Hong Kong, India, Iraq, Ireland, Israel, Italy, Ivory Coast, Jamaica, Jordan, Kazakhstan, Kenya, Kuwait, Kyrgyzstan, Latvia, Lebanon, Libya. Lithuania, Luxembourg, Macedonia, Malaysia, Maldives, Mali, Mauritania, Mexico, Moldova, Montenegro, Morocco, Namibia, Netherlands, New Zealand, Norway, Oman, Pakistan, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Republic of Yemen, Romania, Russia, Rwanda, Saudi Arabia, Senegal, Serbia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Tanzania, Thailand, Trinidad & Tobago, Tunisia, Turkey, Turks and Caicos, Tunisia, UAE, United Kingdom,...
- How much
- 22,359 kits
C3 is an in vitro diagnostic assay for the quantitative determination of C3 in human serum or plasma. Antibod
Z-1987-2019 · Class II · reported 2019-07-31 · Terminated
- Why it was recalled
- An update to the Reagents and Specimen Collection and Handling/Preparation for Analysis sections of the IFU was required due to different issues with the various products.
- Product
- C3 is an in vitro diagnostic assay for the quantitative determination of C3 in human serum or plasma. Antibodies to C3 combine with C3 in the sample to form insoluble immune complexes. The immune complexes cause an increase in light scattering (turbidity). The resulting increase in sample turbidity, measured at 604 nm, is directly proportional to the concentration of C3 in the sample.
- Where it went
- Distribution was nationwide, including Puerto Rico. There was government/military distribution. Foreign distribution was made to Canada, Albania, Algeria, Andorra, Argentina, Armenia, Australia, Austria, Azerbaijan, Bangladesh, Belarus, Belgium, Bolivia, Bosnia and Herzegovi, Botswana, Brazil, Brunei, Bulgaria, Chile, China, Costa Rica, Croatia, Curacao (Netherlands Antilles), Cyprus, Czech Republic, Democratic Republic of the Congo, Denmark, Ecuador, Egypt, Estonia, Finland, France, Gaza & Jericho, Germany, Greece, Greenland, Honduras, Hong Kong, India, Iraq, Ireland, Israel, Italy, Ivory Coast, Jamaica, Jordan, Kazakhstan, Kenya, Kuwait, Kyrgyzstan, Latvia, Lebanon, Libya. Lithuania, Luxembourg, Macedonia, Malaysia, Maldives, Mali, Mauritania, Mexico, Moldova, Montenegro, Morocco, Namibia, Netherlands, New Zealand, Norway, Oman, Pakistan, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Republic of Yemen, Romania, Russia, Rwanda, Saudi Arabia, Senegal, Serbia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Tanzania, Thailand, Trinidad & Tobago, Tunisia, Turkey, Turks and Caicos, Tunisia, UAE, United Kingdom,...
- How much
- 8,132 kits
The,K -ASSAY HP assay is intended for the quantitative determination of human haptoglobin by immunoturbidime
Z-1993-2019 · Class II · reported 2019-07-31 · Terminated
- Why it was recalled
- An update to the Reagents and Specimen Collection and Handling/Preparation for Analysis sections of the IFU was required due to different issues with the various products.
- Product
- The,K -ASSAY HP assay is intended for the quantitative determination of human haptoglobin by immunoturbidimetric assay. The antiserum used in the kit was produced against purified human haptoglobin. The haptoglobin antibody interacts with the haptoglobin in the serum forming immune complexes . The immune complexes cause an increase in light scattering which correlates with the concentration of haptoglobin.
- Where it went
- Distribution was nationwide, including Puerto Rico. There was government/military distribution. Foreign distribution was made to Canada, Albania, Algeria, Andorra, Argentina, Armenia, Australia, Austria, Azerbaijan, Bangladesh, Belarus, Belgium, Bolivia, Bosnia and Herzegovi, Botswana, Brazil, Brunei, Bulgaria, Chile, China, Costa Rica, Croatia, Curacao (Netherlands Antilles), Cyprus, Czech Republic, Democratic Republic of the Congo, Denmark, Ecuador, Egypt, Estonia, Finland, France, Gaza & Jericho, Germany, Greece, Greenland, Honduras, Hong Kong, India, Iraq, Ireland, Israel, Italy, Ivory Coast, Jamaica, Jordan, Kazakhstan, Kenya, Kuwait, Kyrgyzstan, Latvia, Lebanon, Libya. Lithuania, Luxembourg, Macedonia, Malaysia, Maldives, Mali, Mauritania, Mexico, Moldova, Montenegro, Morocco, Namibia, Netherlands, New Zealand, Norway, Oman, Pakistan, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Republic of Yemen, Romania, Russia, Rwanda, Saudi Arabia, Senegal, Serbia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Tanzania, Thailand, Trinidad & Tobago, Tunisia, Turkey, Turks and Caicos, Tunisia, UAE, United Kingdom,...
- How much
- 5,694 kits
Abbott ARCHITECT cSystems ICT Module, REF 09D28-03. Product Usage: The ARCHITECT cSystems ICT (Integrated
Z-1296-2019 · Class II · reported 2019-05-15 · Terminated
- Why it was recalled
- There is a potential to generate falsely elevated serum or plasma chloride results when using the product.
- Product
- Abbott ARCHITECT cSystems ICT Module, REF 09D28-03. Product Usage: The ARCHITECT cSystems ICT (Integrated Chip Technology) is used for the quantitation of sodium, potassium, and chloride in human serum, plasma, or urine.
- Where it went
- Worldwide Distribution - US Nationwide in the states of AR, CA, CT, FL, IA, IN, LA, MA, MD, MS, NJ, NY, PA, SC, TX, VT, WA, and WV. There was government distribution and no military distribution. Foreign distribution was made to Australia, China, Hong Kong, and New Zealand.
- How much
- 99 modules/kits
Abbott ARCHITECT c4000 Processing Module, List No. 02P24 - Product Usage: The Abbott ARCHITECT System is inten
Z-1102-2019 · Class II · reported 2019-04-17 · Terminated
- Why it was recalled
- There is a potential to generate incorrect results on the instrument if particular error codes are not resolved before transitioning to the Running status.
- Product
- Abbott ARCHITECT c4000 Processing Module, List No. 02P24 - Product Usage: The Abbott ARCHITECT System is intended for In Vitro diagnostic use only. The Abbott ARCHITECT Clinical Chemistry Systems are designed to perform automated chemistry tests, utilizing photometry and potentiometric technology. The ARCHITECT c4000, c8000, c16000 sample pipettor assemblies include a fluid sense/pressure monitoring system that helps identify errors in aspiration.
- Where it went
- Worldwide distribution - US Nationwide and countries Afghanistan, Albania, Algeria, Angola, Argentina, Armenia, Australia, Austria, Azerbaijan, Bahamas, Bangladesh, Belarus, Belgium, Bermuda, Bosnia and Herzegovina, Brazil, Brunei, Bulgaria, Burkina FASO, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, Croatia, Curacao, Cyprus, Czech Republic, Democratic Rep. of Congo, Denmark, Dominican Republic, Ecuador, Egypt, El Salvador, Estonia, Ethiopia, Finland, France, Georgia, Germany, Ghana, Greece, Guatemala, Honduras, Hong Kong, Hungary, India, Indonesia, Iraq, Ireland, Israel, Italy, Ivory Coast, Jamaica, Jordan, Kazakhstan, Kenya, Kuwait, Kyrgyzstan, Latvia, Lebanon, Libya, Lithuania, Luxembourg, Macedonia, Malawi, Malaysia, Maldives, Mali, Mauritania, Mauritius, Mexico, Moldova, Montenegro, Montserrat, Morocco, Myanmar, Netherlands, New Zealand, Nigeria, Norway, Oman, Pakistan, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Romania, Russia, Rwanda, Saudi Arabia, Senegal, Serbia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sri Lanka, St. Lucia, St. Vincent, Sweden, Switzerland, Taiwan, Tajikistan, Tanzania, Thailand, Trinidad & Tobago,...
- How much
- 3,675 instruments
Abbott ARCHITECT c16000 Processing Module, List No. 03L77 - Product Usage: The Abbott ARCHITECT System is inte
Z-1104-2019 · Class II · reported 2019-04-17 · Terminated
- Why it was recalled
- There is a potential to generate incorrect results on the instrument if particular error codes are not resolved before transitioning to the Running status.
- Product
- Abbott ARCHITECT c16000 Processing Module, List No. 03L77 - Product Usage: The Abbott ARCHITECT System is intended for In Vitro diagnostic use only. The Abbott ARCHITECT Clinical Chemistry Systems are designed to perform automated chemistry tests, utilizing photometry and potentiometric technology. The ARCHITECT c4000, c8000, c16000 sample pipettor assemblies include a fluid sense/pressure monitoring system that helps identify errors in aspiration.
- Where it went
- Worldwide distribution - US Nationwide and countries Afghanistan, Albania, Algeria, Angola, Argentina, Armenia, Australia, Austria, Azerbaijan, Bahamas, Bangladesh, Belarus, Belgium, Bermuda, Bosnia and Herzegovina, Brazil, Brunei, Bulgaria, Burkina FASO, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, Croatia, Curacao, Cyprus, Czech Republic, Democratic Rep. of Congo, Denmark, Dominican Republic, Ecuador, Egypt, El Salvador, Estonia, Ethiopia, Finland, France, Georgia, Germany, Ghana, Greece, Guatemala, Honduras, Hong Kong, Hungary, India, Indonesia, Iraq, Ireland, Israel, Italy, Ivory Coast, Jamaica, Jordan, Kazakhstan, Kenya, Kuwait, Kyrgyzstan, Latvia, Lebanon, Libya, Lithuania, Luxembourg, Macedonia, Malawi, Malaysia, Maldives, Mali, Mauritania, Mauritius, Mexico, Moldova, Montenegro, Montserrat, Morocco, Myanmar, Netherlands, New Zealand, Nigeria, Norway, Oman, Pakistan, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Romania, Russia, Rwanda, Saudi Arabia, Senegal, Serbia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sri Lanka, St. Lucia, St. Vincent, Sweden, Switzerland, Taiwan, Tajikistan, Tanzania, Thailand, Trinidad & Tobago,...
- How much
- 1,666 instruments
Abbott ARCHITECT c8000 Processing Module, List No. 01G06 - Product Usage: The Abbott ARCHITECT System is inten
Z-1103-2019 · Class II · reported 2019-04-17 · Terminated
- Why it was recalled
- There is a potential to generate incorrect results on the instrument if particular error codes are not resolved before transitioning to the Running status.
- Product
- Abbott ARCHITECT c8000 Processing Module, List No. 01G06 - Product Usage: The Abbott ARCHITECT System is intended for In Vitro diagnostic use only. The Abbott ARCHITECT Clinical Chemistry Systems are designed to perform automated chemistry tests, utilizing photometry and potentiometric technology. The ARCHITECT c4000, c8000, c16000 sample pipettor assemblies include a fluid sense/pressure monitoring system that helps identify errors in aspiration.
- Where it went
- Worldwide distribution - US Nationwide and countries Afghanistan, Albania, Algeria, Angola, Argentina, Armenia, Australia, Austria, Azerbaijan, Bahamas, Bangladesh, Belarus, Belgium, Bermuda, Bosnia and Herzegovina, Brazil, Brunei, Bulgaria, Burkina FASO, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, Croatia, Curacao, Cyprus, Czech Republic, Democratic Rep. of Congo, Denmark, Dominican Republic, Ecuador, Egypt, El Salvador, Estonia, Ethiopia, Finland, France, Georgia, Germany, Ghana, Greece, Guatemala, Honduras, Hong Kong, Hungary, India, Indonesia, Iraq, Ireland, Israel, Italy, Ivory Coast, Jamaica, Jordan, Kazakhstan, Kenya, Kuwait, Kyrgyzstan, Latvia, Lebanon, Libya, Lithuania, Luxembourg, Macedonia, Malawi, Malaysia, Maldives, Mali, Mauritania, Mauritius, Mexico, Moldova, Montenegro, Montserrat, Morocco, Myanmar, Netherlands, New Zealand, Nigeria, Norway, Oman, Pakistan, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Romania, Russia, Rwanda, Saudi Arabia, Senegal, Serbia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sri Lanka, St. Lucia, St. Vincent, Sweden, Switzerland, Taiwan, Tajikistan, Tanzania, Thailand, Trinidad & Tobago,...
- How much
- 3,794 instruments
Abbott ARCHITECT Creatine Kinase, IVD, REF 7D6341.
Z-1076-2019 · Class II · reported 2019-04-10 · Terminated
- Why it was recalled
- The product has a stability issue which may lead to an error code indicating "Unable to calculate result, reaction check failure" and/or Quality Control results out of range low.
- Product
- Abbott ARCHITECT Creatine Kinase, IVD, REF 7D6341.
- Where it went
- Distribution was made nationwide, including Puerto Rico. There was also government and military distribution. Foreign distribution was made to Algeria, Argentina, Australia, Austria, Belarus, Belgium, Bermuda, Bosnia and Herzegovina, Brazil, Brunei, Bulgaria, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, Croatia, Czech Republic, Denmark, Ecuador, Egypt, El Salvador, Estonia, Finland, France, Gaza & Jericho, Germany, Greece, Guatemala, Hong Kong, Hungary, India, Indonesia, Iraq, Ireland, Israel, Italy, Jamaica, Kazakhstan, Kuwait, Latvia, Lebanon, Libya, Lithuania, Luxembourg, Macedonia, Malaysia, Maldives, Mali, Mexico, Moldova, Morocco, Netherlands, Netherlands (Curacao), New Zealand, Norway, Oman, Pakistan, Paraguay, Philippines, Poland, Portugal, Qatar, Republic of Yemen, Romania, Russia, Rwanda, Saudi Arabia, Senegal, Serbia, Singapore, Slovakia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Tanzania, Thailand, Trinidad & Tobago, Tunisia, Turkey, UAE, Uganda, United Kingdom, Uruguay, Vietnam, and Zimbabwe.
- How much
- 30 kits
Abbott ARCHITECT Creatine Kinase, IVD, REF 7D63-21.
Z-1075-2019 · Class II · reported 2019-04-10 · Terminated
- Why it was recalled
- The product has a stability issue which may lead to an error code indicating "Unable to calculate result, reaction check failure" and/or Quality Control results out of range low.
- Product
- Abbott ARCHITECT Creatine Kinase, IVD, REF 7D63-21.
- Where it went
- Distribution was made nationwide, including Puerto Rico. There was also government and military distribution. Foreign distribution was made to Algeria, Argentina, Australia, Austria, Belarus, Belgium, Bermuda, Bosnia and Herzegovina, Brazil, Brunei, Bulgaria, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, Croatia, Czech Republic, Denmark, Ecuador, Egypt, El Salvador, Estonia, Finland, France, Gaza & Jericho, Germany, Greece, Guatemala, Hong Kong, Hungary, India, Indonesia, Iraq, Ireland, Israel, Italy, Jamaica, Kazakhstan, Kuwait, Latvia, Lebanon, Libya, Lithuania, Luxembourg, Macedonia, Malaysia, Maldives, Mali, Mexico, Moldova, Morocco, Netherlands, Netherlands (Curacao), New Zealand, Norway, Oman, Pakistan, Paraguay, Philippines, Poland, Portugal, Qatar, Republic of Yemen, Romania, Russia, Rwanda, Saudi Arabia, Senegal, Serbia, Singapore, Slovakia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Tanzania, Thailand, Trinidad & Tobago, Tunisia, Turkey, UAE, Uganda, United Kingdom, Uruguay, Vietnam, and Zimbabwe.
- How much
- 6,187 kits kits
ARCHITECT MAGNESIUM, (a) REF 7D70-21, (b) 7D70-31 The Magnesium assay is used for the quantitation of magne
Z-0971-2019 · Class II · reported 2019-03-13 · Terminated
- Why it was recalled
- Abbott internal testing has identified that the Magnesium urine application demonstrates depressed urine result recovery. All samples >0.5mEq/L fail the linearity acceptance criteria for the bias specification and demonstrate depressed recovery of up to 37%. The specific cause of the negative bias/depressed results is currently under investigation.
- Product
- ARCHITECT MAGNESIUM, (a) REF 7D70-21, (b) 7D70-31 The Magnesium assay is used for the quantitation of magnesium in human serum, plasma, or urine.
- Where it went
- Worldwide Distribution: US (nationwide) and to countries of: CHINA, THAILAND, GUATEMALA, and EL SALVADOR.
- How much
- 24,995 units
CardioMEMS HF System Hospital and Patient Electronics Units: (a) Patient Electronics System, Model CM1100 (b
Z-2522-2018 · Class II · reported 2018-08-01 · Terminated
- Why it was recalled
- Abbott is advising customers that a small number of CardioMEMS(R) Hospital Electronics Systems (Model CM3000) and Patient Electronics Systems (Model CM1100) may deliver a system error, known as Error 5. While this error message is intended to present if the electronics system exceeds a certain temperature, these units may deliver a false Error 5 message due to an incorrectly configured component within the device electronics.
- Product
- CardioMEMS HF System Hospital and Patient Electronics Units: (a) Patient Electronics System, Model CM1100 (b) Hospital Electronics System, Model CM3000
- Where it went
- US, Canada, Netherlands, Germany, Great Britain, France, Ireland, Belgium
- How much
- 2521 units
ARCHITECT c8000 Cuvette Segment, Part #01G46-01/01G06, a component to the ARCHITECT Clinical Chemistry system.
Z-0922-2018 · Class II · reported 2018-03-14 · Terminated
- Why it was recalled
- There is a potential to generate falsely depressed patient results in the cuvettes adjacent to the detached segment post for any assay run on the c4000, c8000, and c16000 instrument.
- Product
- ARCHITECT c8000 Cuvette Segment, Part #01G46-01/01G06, a component to the ARCHITECT Clinical Chemistry system. There are 11 segments with each cuvette segment holding 15 cuvettes for a total of 165 cuvettes per reaction carousel. The firm name on the label is Abbott Laboratories, Abbott Park, IL. The Abbott ARCHITECT Clinical Chemistry Systems are designed to perform automated chemistry tests utilizing photometry and potentiometric technology. The cuvette segments are a component of the system and are racks that sit in the reaction carousel and hold cuvettes.
- Where it went
- Worldwide Distribution: US (nationwide) including Puerto Rico and countries of: Afghanistan, Albania, Algeria, Angola, Argentina, Armenia, Australia, Austria, Azerbaijan, Bahamas, Bangladesh, Belarus, Belgium, Bosnia and Herzegovina, Brazil, Brunei, Bulgaria, Burkina Faso, Cameroon, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, Croatia, Curacao, Cyrus, Czech Republic, Dem Rep of The Congo, Denmark, Dominican Republic, Ecuador, Egypt, El Salvador, Estonia, Ethiopia, Finland, France, Gaza & Jericho, Georgia, Germany, Greece, Guatemala, Honduras, Hong Kong, Hungary, India, Indonesia, Iraq, Ireland, Israel, Italy, Ivory Coast, Jamaica, Jordan, Kazakhstan, Kenya, Kuwait, Kyrgyzstan, Latvia, Lebanon, Libya, Lithuania, Luxembourg, Macedonia, Malawi, Malaysia, Maldives, Mali, Mauritania, Mexico, Moldova, Montenegro, Montserrat, Morocco, Netherlands, New Zealand, Nigeria, North Yemen, Norway, Oman, Pakistan, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Romania, Russia (CIS), Saudi Arabia, Senegal, Serbia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, St. Lucia, St. Vincent, Sweden, Switzerland, Taiwan, Tajikistan, Tanzania, Thailand,...
- How much
- 3,357 ARCHITECT c8000 Systems
ARCHITECT c4000 Cuvette Segment, Part #02P75-01/02P24, a component to the ARCHITECT Clinical Chemistry system.
Z-0921-2018 · Class II · reported 2018-03-14 · Terminated
- Why it was recalled
- There is a potential to generate falsely depressed patient results in the cuvettes adjacent to the detached segment post for any assay run on the c4000, c8000, and c16000 instrument.
- Product
- ARCHITECT c4000 Cuvette Segment, Part #02P75-01/02P24, a component to the ARCHITECT Clinical Chemistry system. There are 9 segments with each cuvette segment holding 11 cuvettes for a total of 99 cuvettes per reaction carousel. The firm name on the label is Abbott Laboratories, Abbott Park, IL. The Abbott ARCHITECT Clinical Chemistry Systems are designed to perform automated chemistry tests utilizing photometry and potentiometric technology. The cuvette segments are a component of the system and are racks that sit in the reaction carousel and hold cuvettes.
- Where it went
- Worldwide Distribution: US (nationwide) including Puerto Rico and countries of: Afghanistan, Albania, Algeria, Angola, Argentina, Armenia, Australia, Austria, Azerbaijan, Bahamas, Bangladesh, Belarus, Belgium, Bosnia and Herzegovina, Brazil, Brunei, Bulgaria, Burkina Faso, Cameroon, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, Croatia, Curacao, Cyrus, Czech Republic, Dem Rep of The Congo, Denmark, Dominican Republic, Ecuador, Egypt, El Salvador, Estonia, Ethiopia, Finland, France, Gaza & Jericho, Georgia, Germany, Greece, Guatemala, Honduras, Hong Kong, Hungary, India, Indonesia, Iraq, Ireland, Israel, Italy, Ivory Coast, Jamaica, Jordan, Kazakhstan, Kenya, Kuwait, Kyrgyzstan, Latvia, Lebanon, Libya, Lithuania, Luxembourg, Macedonia, Malawi, Malaysia, Maldives, Mali, Mauritania, Mexico, Moldova, Montenegro, Montserrat, Morocco, Netherlands, New Zealand, Nigeria, North Yemen, Norway, Oman, Pakistan, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Romania, Russia (CIS), Saudi Arabia, Senegal, Serbia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, St. Lucia, St. Vincent, Sweden, Switzerland, Taiwan, Tajikistan, Tanzania, Thailand,...
- How much
- 3,634 ARCHITECT c4000 systems
ARCHITECT c16000 Cuvette Segment, Part #09D32-05/ 03L77, a component to the ARCHITECT Clinical Chemistry syste
Z-0923-2018 · Class II · reported 2018-03-14 · Terminated
- Why it was recalled
- There is a potential to generate falsely depressed patient results in the cuvettes adjacent to the detached segment post for any assay run on the c4000, c8000, and c16000 instrument.
- Product
- ARCHITECT c16000 Cuvette Segment, Part #09D32-05/ 03L77, a component to the ARCHITECT Clinical Chemistry system. There are 15 segments with each cuvette segment holding 11 cuvette pairs (22 cuvettes) for a total of 165 cuvettes pairs or a total of 330 cuvettes (22 cuvettes x 15 cuvette segments) per reaction carousel. The firm name on the label is Abbott Laboratories, Abbott Park, IL. The Abbott ARCHITECT Clinical Chemistry Systems are designed to perform automated chemistry tests utilizing photometry and potentiometric technology. The cuvette segments are a component of the system and are racks that sit in the reaction carousel and hold cuvettes.
- Where it went
- Worldwide Distribution: US (nationwide) including Puerto Rico and countries of: Afghanistan, Albania, Algeria, Angola, Argentina, Armenia, Australia, Austria, Azerbaijan, Bahamas, Bangladesh, Belarus, Belgium, Bosnia and Herzegovina, Brazil, Brunei, Bulgaria, Burkina Faso, Cameroon, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, Croatia, Curacao, Cyrus, Czech Republic, Dem Rep of The Congo, Denmark, Dominican Republic, Ecuador, Egypt, El Salvador, Estonia, Ethiopia, Finland, France, Gaza & Jericho, Georgia, Germany, Greece, Guatemala, Honduras, Hong Kong, Hungary, India, Indonesia, Iraq, Ireland, Israel, Italy, Ivory Coast, Jamaica, Jordan, Kazakhstan, Kenya, Kuwait, Kyrgyzstan, Latvia, Lebanon, Libya, Lithuania, Luxembourg, Macedonia, Malawi, Malaysia, Maldives, Mali, Mauritania, Mexico, Moldova, Montenegro, Montserrat, Morocco, Netherlands, New Zealand, Nigeria, North Yemen, Norway, Oman, Pakistan, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Romania, Russia (CIS), Saudi Arabia, Senegal, Serbia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, St. Lucia, St. Vincent, Sweden, Switzerland, Taiwan, Tajikistan, Tanzania, Thailand,...
- How much
- 1,560 ARCHITECT c16000 Systems
ARCHITECT c4000 part number 02P24; ARCHITECT c8000 part number 01G06; ARCHITECT c16000 part number 03L77 Clin
Z-0165-2018 · Class II · reported 2017-11-29 · Completed
- Why it was recalled
- The Peristaltic Head tubing placed on the ARCHITECT c4000, c8000, and c16000 has the possibility to leak due to a manufacturing issue associated with the tubing connector.
- Product
- ARCHITECT c4000 part number 02P24; ARCHITECT c8000 part number 01G06; ARCHITECT c16000 part number 03L77 Clinical Chemistry systems.
- Where it went
- Worldwide distribution to US, Canada, France, and Germany.
- How much
- 34 units
Tubing, Peristaltic Head Part Number 7-35009685-01 for use in clinical chemistry systems.
Z-0166-2018 · Class II · reported 2017-11-29 · Completed
- Why it was recalled
- The Peristaltic Head tubing placed on the ARCHITECT c4000, c8000, and c16000 has the possibility to leak due to a manufacturing issue associated with the tubing connector.
- Product
- Tubing, Peristaltic Head Part Number 7-35009685-01 for use in clinical chemistry systems.
- Where it went
- Worldwide distribution to US, Canada, France, and Germany.
- How much
- 44 units
ARCHITECT c4000 Cuvette Segment, List number 02P75-01. The firm name on the label is Abbott Laboratories, Abb
Z-0011-2018 · Class II · reported 2017-10-18 · Terminated
- Why it was recalled
- There is a potential to generate falsely-depressed patient results in the cuvettes adjacent to the detached segment post for any assay run on the c4000 instrument.
- Product
- ARCHITECT c4000 Cuvette Segment, List number 02P75-01. The firm name on the label is Abbott Laboratories, Abbott Park, IL. Cuvette segments are a component to the ARCHITECT c4000 system. Cuvette segments are racks that sit in the reaction carousel and hold cuvettes. Each cuvette segment holds 11 cuvettes. With 9 segments, the reaction carousel holds 99 cuvettes. The Abbott ARCHITECT System is intended for In Vitro diagnostic use only. The system is designed to perform automated chemistry tests, utilizing photometry and potentiometric technology.
- Where it went
- Worldwide Distribution: US (nationwide) including Puerto Rico, and countries of: Algeria, Angola, Argentina, Armenia, Australia, Austria, Azerbaijan, Bahamas, Bangladesh, Belarus, Belgium, Bosnia & Herzegovina, Brazil, Brunei, Bulgaria Burkina Faso, Canada, Chile, China, Columbia, Costa Rica, Croatia, Czech Republic, Ecuador, Egypt, El Salvador, Estonia, Ethiopia, Finland, France, Gaza & Jericho, Georgia, Germany, Ghana, Greece, Guatemala, Honduras, Hong Kong, Hungary, India, Indonesia, Iraq, Ireland, Israel, Italy, Ivory Coast, Jordan, Kazakhstan, Kenya, Kuwait, Kyrgyzstan, Latvia, Lebanon, Libya, Lithuania, Macedonia, Malawi, Malaysia, Maldives, Mali, Mauritania, Mexico, Morocco, Netherlands, New Zealand, Nigeria, North Yemen, Oman, Pakistan, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Romania, Russia (CIS), Saudi Arabia, Senegal, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, St. Lucia, Sweden, Switzerland, Tajikistan, Tanzania, Thailand, Trinidad & Tobago, Tunisia, Turkey, Turks & Caicos, UAE, Uganda, United Kingdom, Uruguay, Venezuela, Viet Nam, Zambia, and Zimbabwe.
- How much
- 1,385 cuvette segments
ARCHITECT i2000SR System The Abbott ARCHITECT System is intended for In Vitro diagnostic use only. The ARCHI
Z-0163-2016 · Class II · reported 2015-11-04 · Terminated
- Why it was recalled
- Incorrect tubing.
- Product
- ARCHITECT i2000SR System The Abbott ARCHITECT System is intended for In Vitro diagnostic use only. The ARCHITECT system is designed to perform automated immunoassay tests, utilizing CMIA (chemiluminescent microparticle assay) detection technology.
- Where it went
- Worldwide Distribution - US (nationwide) and Internationally to France, Netherlands, Greece, Italy, Belgium, India, Austria, Germany, and Japan
- How much
- 65 units
Lipase Reagent, 7D80. Used to measure lipase in human serum on the Architect system.
Z-0131-2015 · Class II · reported 2014-11-05 · Terminated
- Why it was recalled
- Package inserts have incorrect SmartWash parameters for Triglyceride.
- Product
- Lipase Reagent, 7D80. Used to measure lipase in human serum on the Architect system.
- Where it went
- Worldwide Distribution: US (nationwide) and countries of: Algeria, Angola, Argentina, Armenia, Australia, Austria, Bangladesh, Belgium, Bosnia and Herzegovina, Brazil, Bulgaria, Canada, Chile, China, Columbia, Croatia, Czech Republic, Dominican Republic, Egypt, Estonia, France, Germany, Greece, Guatemala, Hungary, India, Indonesia, Iraq, Ireland, Israel, Italy, Jamaica, Jordan, Kenya, Kuwait, Kyrgyzstan, Latvia, Lebanon, Libya, Lithuania, Luxembourg, Moldova, Montenegro, Morocco, Netherlands, New Zealand, Norway, Pakistan, Panama, Paraguay, Philippines, Poland, Portugal, Qatar, Republic of Yemen, Romania, Saudi Arabia, Senegal, Serbia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Trinidad and Tobago, Tunisia, Turks and Caicos, Turkey, Uganda, United Arab Emirates, United Kingdom, and Uruguay.
- How much
- 11916 units
Clinical Chemistry Phosphorus Reagent The Phosphorus assay is used for the quantitation of phosphorus in h
Z-0020-2014 · Class II · reported 2013-10-23 · Terminated
- Why it was recalled
- Reagent lots 64736UN12, 03991UN13, 51611UN13, 74805UN12, and 03992UN13 have incorrect expiration dates assigned by Supplier.
- Product
- Clinical Chemistry Phosphorus Reagent The Phosphorus assay is used for the quantitation of phosphorus in human serum, plasma, or urine.
- Where it went
- Worldwide distribution: US (nationwide) including Puerto Rico and countries of: Albania, Algeria, Argentina, Austria, Australia, Azerbaijan, Bangladesh, Bahamas, Belgium, Bosnia & Herzegovina, Brazil, Bulgaria, Burkina, Canada, Cayman Islands, Chile, China, Columbia, Croatia, Curacao, Cyprus, Czech Republic, Denmark, Dominican Republic, El Salvador, Egypt, Estonia, Ethiopia, Finland, France, Germany, Greece, Guatemala, Hong Kong, India, Iraq, Ireland, Israel, Italy, Ivory Coast, Jamaica, Jordan, Kazakhstan, Kenya, Kuwait, Latvia, Lebanon, Libya, Lithuania, Luxembourg, Malaysia, Mali, Mauritania ,Mexico, Moldova, Morocco, Netherlands, New Zealand, Norway, Oman, Pakistan, Panama, Paraguay, Philippines, Poland, Portugal, Qatar, Republic of Yemen, Romania, Russia, Saudi Arabia, Senegal, Serbia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Tajikistan, Taiwan, Tanzania, Thailand, Trinidad & Tobago, Tunisia, Turkey, Turks and Caicos, United Arab Emirates, United Kingdom, Uruguay and Vietnam.
- How much
- 7213
Showing the 30 most recent of 32. The rest are searchable at the FDA enforcement report database.
Read these counts with three things in mind
A firm with more recalls usually makes more products. A contract packer runs
hundreds of lines. It will out-recall a company with one product whatever either
does. This is not a safety ranking.
Most recalls here are voluntary. A firm found its own fault and pulled the stock.
That is the system working. It lands in this database looking the same as a recall
the FDA had to push for.
Terminated means the FDA considers the recall finished. It is not a verdict.
It does not mean anyone was harmed.
Source: openFDA enforcement reports, retrieved 2026-08-05. FDA dataset last updated 2026-07-29.
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