Abbott Molecular, Inc.: 30 FDA recall reports
Every medical device recall the FDA has published for Abbott Molecular, Inc.. The fault, and how the agency graded it.
30Reports
5Class I
21Ongoing
2025-05-21Most recent
5 Class I on this pageClass I means the FDA judged there was a reasonable probability of serious harm or death. Check the lot numbers against anything you hold.
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 m Resp-4-Plex AMP Kit, List Number 09N79-096, a multiplex real-time reverse transcription (RT) polymer
Z-1749-2025 · Class II · reported 2025-05-21 · Ongoing
- Why it was recalled
- There were reports of an increase in reactive negative controls and false positive results.
- Product
- Alinity m Resp-4-Plex AMP Kit, List Number 09N79-096, a multiplex real-time reverse transcription (RT) polymerase chain reaction (PCR) test intended for the simultaneous qualitative detection and differentiation of RNA from SARS-CoV-2, influenza A virus (flu A), influenza B virus (flu B), and/or Respiratory Syncytial Virus (RSV) in anterior nasal or nasopharyngeal swab specimens collected by a healthcare provider (HCP), or in anterior nasal swab specimens that are self-collected at a healthcare location, from individuals suspected by their HCP of respiratory viral infection consistent with COVID-19.
- Where it went
- Worldwide - US Nationwide distribution.
- How much
- 656 units
Alinity m Resp-4-Plex Amplification (AMP) Kit (CE), List Number 09N79-090, a multiplex real-time reverse trans
Z-1748-2025 · Class II · reported 2025-05-21 · Ongoing
- Why it was recalled
- There were reports of an increase in reactive negative controls and false positive results.
- Product
- Alinity m Resp-4-Plex Amplification (AMP) Kit (CE), List Number 09N79-090, a multiplex real-time reverse transcription (RT) polymerase chain reaction (PCR) test intended for the qualitative detection and differentiation of RNA from influenza A virus (flu A), influenza B virus (flu B), Respiratory Syncytial Virus (RSV), and SARS-CoV-2 in nasopharyngeal (NP) swab specimens collected by a healthcare provider, from individuals with signs and symptoms of respiratory tract infection
- Where it went
- Worldwide - US Nationwide distribution.
- How much
- 1447 units
The Alinity m System is designed to automate the steps for nucleic acid testing. Model Numbers included in thi
Z-1665-2025 · Class II · reported 2025-04-30 · Ongoing
- Why it was recalled
- The design of the Alinity m System Solutions drawer enclosure may allow liquid (liquid waste or system solutions) originating in the System Solutions drawer to flow beyond the footprint of the instrument and into the walking-path of the user.
- Product
- The Alinity m System is designed to automate the steps for nucleic acid testing. Model Numbers included in this recall are 08N53-001, 08N53-002, and 08N53-032 (Refurbished).
- Where it went
- Worldwide - US Nationwide distribution.
- How much
- N/A
Abbott Alinity m HPV AMP Kit, used with the Alinity m System, product codes: a) REF 09N15-095; b) REF 09N15-0
Z-0233-2025 · Class II · reported 2024-11-06 · Ongoing
- Why it was recalled
- Abbott has identified an increase of incidences regarding Error Code (EC) 9198 (Positive control is non-reactive) while using the Alinity m HR HPV AMP Kit and Alinity m STI AMP Kit. Certain invalidated positive assay controls can be traced to iron leaching into the Alinity m Lysis Solution from the lysis transfer pump in the Alinity m System.
- Product
- Abbott Alinity m HPV AMP Kit, used with the Alinity m System, product codes: a) REF 09N15-095; b) REF 09N15-090; c) REF 09N15-091
- Where it went
- Worldwide distribution: US (nationwide) to states of: AZ, CA, CO, DC, FL, GA, IN, IL, LA, MA, MI, MN, MO, NC, NE, NJ, NY, OR, PA, SC, TN, TX, VA, WA, and WI; and foreign (OUS) countries of: AUSTRIA, BELGUIM, BULGARIA, CAMBODIA, CANADA, COSTA RICA, CROATIA, CZECH REPUBLIC, DOMINICAN REP., EL SALVADOR, ESTONIA, FINLAND, FRANCE, GERMANY, GREECE, IRELAND, ISRAEL, ITALY, KAZAKHSTAN, KENYA, LUXEMBOURG, MALAWI, MALAYSIA, MONTENEGRO, MOROCCO, NETHERLANDS, NORWAY, POLAND, PORTUGAL, ROMANIA, SAUDIA ARABIA, SINGAPORE, SLOVENIA, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, TANZANIA, THAILAND, UNITED KINGDOM, AND VIETNAM.
- How much
- 13318 units
Abbott Alinity m STI AMP Kit, used with the Alinity m System, product codes: a) REF 09N17-095; b) REF 09N17-09
Z-0234-2025 · Class II · reported 2024-11-06 · Ongoing
- Why it was recalled
- Abbott has identified an increase of incidences regarding Error Code (EC) 9198 (Positive control is non-reactive) while using the Alinity m HR HPV AMP Kit and Alinity m STI AMP Kit. Certain invalidated positive assay controls can be traced to iron leaching into the Alinity m Lysis Solution from the lysis transfer pump in the Alinity m System.
- Product
- Abbott Alinity m STI AMP Kit, used with the Alinity m System, product codes: a) REF 09N17-095; b) REF 09N17-090; c) REF 09N17-091;
- Where it went
- Worldwide distribution: US (nationwide) to states of: AZ, CA, CO, DC, FL, GA, IN, IL, LA, MA, MI, MN, MO, NC, NE, NJ, NY, OR, PA, SC, TN, TX, VA, WA, and WI; and foreign (OUS) countries of: AUSTRIA, BELGUIM, BULGARIA, CAMBODIA, CANADA, COSTA RICA, CROATIA, CZECH REPUBLIC, DOMINICAN REP., EL SALVADOR, ESTONIA, FINLAND, FRANCE, GERMANY, GREECE, IRELAND, ISRAEL, ITALY, KAZAKHSTAN, KENYA, LUXEMBOURG, MALAWI, MALAYSIA, MONTENEGRO, MOROCCO, NETHERLANDS, NORWAY, POLAND, PORTUGAL, ROMANIA, SAUDIA ARABIA, SINGAPORE, SLOVENIA, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, TANZANIA, THAILAND, UNITED KINGDOM, AND VIETNAM.
- How much
- 15068 units
Alinity m System, Part Number: 08N53-002
Z-1602-2024 · Class II · reported 2024-05-01 · Ongoing
- Why it was recalled
- The Alinity m System camera detects whether tubes are "capped." If the camera detects a cap and the retention bar is not present on the sample rack, the system will generate the message 'Error - 6013: Has cap, no retention bar." Abbott has identified an issue concerning the use of certain third-party Universal Transport Medium (UTM) tubes on the Alinity m System. This issue has been observed with Copan UTM-RT 3 mL Without Beads Transport & Preservation Medium for Viral Molecular Diagnostics Testing, Part Number (PN) 3C047N. However, it is possible that other third party manufactured tubes could experience the same issue.
- Product
- Alinity m System, Part Number: 08N53-002
- Where it went
- Worldwide distribution - US Nationwide and the countries ARGENTINA, AUSTRALIA, AUSTRIA, AZERBAIJAN, BELGIUM, BOSNIA AND HERZEGOVINA, BRAZIL, BULGARIA, CAMBODIA, CAMEROON, CANADA, CHILE, CHINA, COLOMBIA, COSTA RICA, CROATIA, CZECH REPUBLIC, EGYPT, EL SALVADOR, ESTONIA, ETHIOPIA, FINLAND, FRANCE, GERMANY, GREECE, HONG KONG, INDIA, IRELAND, ISRAEL, ITALY, JAPAN, KAZAKHSTAN, KENYA, LATVIA, LUXEMBOURG, MALAWI, MALAYSIA, MEXICO, MONTENEGRO, MOROCCO, MOZAMBIQUE, NETHERLANDS, NEW ZEALAND, NIGERIA, NORWAY, PAKISTAN, PANAMA, PARAGUAY, POLAND, PORTUGAL, ROMANIA, RUSSIA (CIS), SAUDI ARABIA, SINGAPORE, SLOVENIA, SOUTH AFRICA, SOUTH KOREA, SPAIN, SWEDEN, SWITZERLAND, TAIWAN, TANZANIA, THAILAND, TURKEY, UGANDA, UNITED KINGDOM, VIETNAM, ZIMBABWE.
- How much
- 1,012 units
Wash station: M1000 Wash Station Assembly & DITI Slide, REF 04J72-28* (*This part number is a spare to the M2
Z-1190-2024 · Class III · reported 2024-03-06 · Ongoing
- Why it was recalled
- Products that were intended for export only which were not approved or registered in accordance with U.S. specifications were shipped to U.S. customers.
- Product
- Wash station: M1000 Wash Station Assembly & DITI Slide, REF 04J72-28* (*This part number is a spare to the M2000sp.)
- Where it went
- US Nationwide distribution in the states of AL, CA, IL, MA, MD, MN, NY, and PA.
In-vitro diagnostic kits: (1) Abbott Vysis MDM2 / CEP 12 FISH Probe Kit, REF 01N15-010; (2) Abbott Vysis L
Z-1188-2024 · Class III · reported 2024-03-06 · Ongoing
- Why it was recalled
- Products that were intended for export only which were not approved or registered in accordance with U.S. specifications were shipped to U.S. customers.
- Product
- In-vitro diagnostic kits: (1) Abbott Vysis MDM2 / CEP 12 FISH Probe Kit, REF 01N15-010; (2) Abbott Vysis LSI D13S319 (13q14.3) SpectrumOrange Probe, REF 01N34-020;
- Where it went
- US Nationwide distribution in the states of AL, CA, IL, MA, MD, MN, NY, and PA.
- How much
- 16 kits
In-vitro diagnostic kits: (1) Abbott Vysis LSI ATM (11q22.3) SpectrmOrange Probe, REF 01N33-020; (2) Abbot
Z-1189-2024 · Class III · reported 2024-03-06 · Ongoing
- Why it was recalled
- Products that were intended for export only which were not approved or registered in accordance with U.S. specifications were shipped to U.S. customers.
- Product
- In-vitro diagnostic kits: (1) Abbott Vysis LSI ATM (11q22.3) SpectrmOrange Probe, REF 01N33-020; (2) Abbott Vysis PTEN/CEP 10 FISH Probe Kit, REF 04N62-020; (3) Abbott Vysis TelVysion 1p SpectrumGreen Probe, REF 05J03-001; (4) Abbott Vysis TelVysion 4P SpectrumGreen Probe, REF 05J03-004; (5) Abbott Vysis TelVysion 22q SpectrumOrange Probe, REF 05J04-022;
- Where it went
- US Nationwide distribution in the states of AL, CA, IL, MA, MD, MN, NY, and PA.
- How much
- 7 kits
Alinity m HCV AMP kit, List (REF) Numbers: a) 08N50-095 and b) 08N50-090. The Alinity m HCV assay is an in vi
Z-0407-2024 · Class II · reported 2023-12-06 · Ongoing
- Why it was recalled
- Abbott has received reports of an increase in reactive negative controls and false positive results in patient samples when using the Identified Lots of Alinity m HCV AMP Kit.
- Product
- Alinity m HCV AMP kit, List (REF) Numbers: a) 08N50-095 and b) 08N50-090. The Alinity m HCV assay is an in vitro reverse transcription-polymerase chain reaction (RT-PCR) assay for use with the automated Alinity m System to detect and quantitate hepatitis C virus (HCV) RNA in human serum or plasma.
- Where it went
- Worldwide
- How much
- 1,881 units
Abbott Alinity m System, REF 08N53-002, containing Amplification Detetction Unit (ADU) #4.
Z-1349-2023 · Class II · reported 2023-04-12 · Ongoing
- Why it was recalled
- The instrument was found to be installed without plunger assemblies in the clamp bar for an Amplification Detection Unit. After correction of the issue, the instrument was returned for use without calibration. This would result in a potential for delay of results and incorrect results.
- Product
- Abbott Alinity m System, REF 08N53-002, containing Amplification Detetction Unit (ADU) #4.
- Where it went
- US Distribution to state of: PA, a government account.
- How much
- 1
Alinity m System. The Alinity m System is designed to automate the steps for nucleic acid testing, which
Z-1009-2023 · Class II · reported 2023-02-01 · Ongoing
- Why it was recalled
- The firm identified the following three potential issues which may have impacted ADUs installed on distributed Alinity m Systems. 1. Systems which had their ADUs serviced may have an incorrect board value (calibration data file) referenced causing a misconfiguration of the calibration. 2. Inability of Maintenance and Diagnostics 2300 (Amp Detect Optical Calibrations) to recognize error handling and thermal hold errors during the calibration process, potentially leading to a misconfiguration of the calibration. 3. Under specific conditions during the ADU manufacturing process, an incorrect calibration may potentially have been configured.
- Product
- Alinity m System. The Alinity m System is designed to automate the steps for nucleic acid testing, which includes sample processing, amplification, detection, and data reduction.
- Where it went
- x
- How much
- 918 units
Abbott Alinity m Resp-4-Plex Amp Kit, Part Number 09N79-096
Z-0739-2023 · Class II · reported 2022-12-28 · Ongoing
- Why it was recalled
- Reports of an increase in reactive negative controls and false positive results with certain lots of Alinity M Resp-4-Plex AMP kits.
- Product
- Abbott Alinity m Resp-4-Plex Amp Kit, Part Number 09N79-096
- Where it went
- Worldwide
- How much
- 3896 kits
Abbott Alinity m Resp-4-Plex Amp Kit, Part Number 09N79-090
Z-0740-2023 · Class II · reported 2022-12-28 · Ongoing
- Why it was recalled
- Reports of an increase in reactive negative controls and false positive results with certain lots of Alinity M Resp-4-Plex AMP kits.
- Product
- Abbott Alinity m Resp-4-Plex Amp Kit, Part Number 09N79-090
- Where it went
- Worldwide
- How much
- 12116 kits
Alinity m System, REF 08N53-002, For In Vitro Diagnostic Use
Z-0268-2023 · Class II · reported 2022-11-30 · Ongoing
- Why it was recalled
- Abbott has identified potential performance issues for the Alinity m System software version 1.6.5: 1) In a unique scenario, the waste chute flapper was found to not open when the Systems Solution drawer was closed and locked. It was found that the software will cause the flapper door to stay in the closed position when the drawer is closed and locked if the flapper had previously been moved out of position. 2) Sample preparation drawer #1 barcode information is used instead of sample prep drawer #2 when the scanned data is not sent to the System Control Center before the next bottle barcode in sample prep drawer#2 is scanned. 3) Under a specific condition, while the system is processing tests and a new test request is made, when the level of the bulk solution is too low to process a test, the software would error stop the system and try to complete all in-process tests. An internal counter is reset which can cause reaction vessels (RVs) already present in an Amplification Detection Unit (or amp detect) to remain there and not be moved to waste so that more RVs can be placed into the amp detect for processing. 4) 4 to 6 replicates of the same auto calibrator orders can be...
- Product
- Alinity m System, REF 08N53-002, For In Vitro Diagnostic Use
- Where it went
- Worldwide distribution.
- How much
- 883 units
Abbott Alinity m SARS-CoV-2 CTRL Kit, REF 09N78-085, each kit contains 12 x 1.3mL CTRL - and 12 x 1.3 mL CTRL
Z-1679-2022 · Class II · reported 2022-09-14 · Ongoing
- Why it was recalled
- Reports received of an increase of message code 9186 (internal control failed) when using the kit.
- Product
- Abbott Alinity m SARS-CoV-2 CTRL Kit, REF 09N78-085, each kit contains 12 x 1.3mL CTRL - and 12 x 1.3 mL CTRL +, For In Vitro Diagnostic Use.
- Where it went
- Distribution was made to AZ, CA, CT, FL, GA, IL, KS, KY, LA, MA, MI, MN, MO, NC, NJ, NV, NY, OK, PA, RI, TN, TX, WA, and WI. There was government distribution but no military distribution. Foreign distribution was made to Chile and Taiwan.
- How much
- 579 kits
The Alinity m System, REF 08N53-002, For In Vitro Diagnostic Use.
Z-1518-2022 · Class II · reported 2022-08-24 · Completed
- Why it was recalled
- Incorrect optical calibration
- Product
- The Alinity m System, REF 08N53-002, For In Vitro Diagnostic Use.
- Where it went
- There was only foreign distribution to Italy.
- How much
- 1
Alinity m HBV AMP Kit (US and CE)
Z-0884-2022 · Class II · reported 2022-04-13 · Ongoing
- Why it was recalled
- There is a potential for misquantitation high results for negative samples.
- Product
- Alinity m HBV AMP Kit (US and CE)
- Where it went
- US consignees - AZ, CA, IL, IN, MA, MI, MO, NH, NJ, NY, OH, SD, TX, and VA OUS consignees - Australia, Austria, Belgium, Brazil, Canada, Columbia, Czech Republic, El Salvador, Estonia, France, Germany, Israel, Italy, Japan, Latvia, Malaysia, Netherlands, New Zealand, Norway, Pakistan, Poland, Portugal, Romania, Russia, Saudi Arabia, Singapore, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, United Kingdom, and Vietnam
- How much
- 4966 kits, updated 101/17/2023
Alinity m HBV Application Specification File (US and CE)
Z-0883-2022 · Class II · reported 2022-04-13 · Ongoing
- Why it was recalled
- There is a potential for misquantitation high results of negative samples.
- Product
- Alinity m HBV Application Specification File (US and CE)
- Where it went
- US consignees - AZ, CA, IL, IN, MA, MI, MO, NH, NJ, NY, OH, SD, TX, and VA OUS consignees - Australia, Austria, Belgium, Brazil, Canada, Columbia, Czech Republic, El Salvador, Estonia, France, Germany, Israel, Italy, Japan, Latvia, Malaysia, Netherlands, New Zealand, Norway, Pakistan, Poland, Portugal, Romania, Russia, Saudi Arabia, Singapore, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, United Kingdom, and Vietnam
Alinity m Integrated Reaction Units (IRU)
Z-0710-2022 · Class II · reported 2022-03-09 · Terminated
- Why it was recalled
- There is potential for the Reaction Vessels (RVs) detaching from the RV cap during transport by the pipettor robot.
- Product
- Alinity m Integrated Reaction Units (IRU)
- Where it went
- US Nationwide distribution in the states of AZ, CA, CO, CT, DC, FL, GA, IL, KY, LA, MA, MI, MO, NC, NJ, NY, OK, RI, SD, TX, WA, and WI.
- How much
- 3063 kits
Alinity m System, Part No. 08N53-002
Z-0460-2022 · Class II · reported 2022-01-12 · Ongoing
- Why it was recalled
- There is a potential for abnormal (non-sigmoidal) amplification curves.
- Product
- Alinity m System, Part No. 08N53-002
- Where it went
- Worldwide distribution - US Nationwide and the countries of Australia, Austria, Belgium, Brazil, Cambodia, Canada, Chile, Colombia, Czech Republic, Egypt, El Salvador, Estonia, Finland, France, Germany, Hong Kong, Ireland, Israel, Italy, Japan, Malawi, Malaysia, Mexico, Montenegro, Morocco, Mozambique, Netherlands, New Zealand, Norway, Pakistan, Poland, Portugal, Romania, Russia, Saudi Arabia, Singapore, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Uganda, United Kingdom, and Vietnam.
- How much
- 742 devices
Alinity m System, Part No. 08N53-002
Z-0461-2022 · Class II · reported 2022-01-12 · Ongoing
- Why it was recalled
- There is a software issue associated with the ability to properly complete a Field Service Engineer Maintenance and Diagnostics procedure.
- Product
- Alinity m System, Part No. 08N53-002
- Where it went
- Worldwide distribution - US Nationwide and the countries of Australia, Austria, Belgium, Brazil, Cambodia, Canada, Chile, Colombia, Czech Republic, Egypt, El Salvador, Estonia, Finland, France, Germany, Hong Kong, Ireland, Israel, Italy, Japan, Malawi, Malaysia, Mexico, Montenegro, Morocco, Mozambique, Netherlands, New Zealand, Norway, Pakistan, Poland, Portugal, Romania, Russia, Saudi Arabia, Singapore, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Uganda, United Kingdom, and Vietnam.
- How much
- 742 devices
Alinity m System, Part No. 08N53-002
Z-0462-2022 · Class II · reported 2022-01-12 · Ongoing
- Why it was recalled
- There is a software defect that can cause the Amplification Detection clamp CLEAN position to be set too high.
- Product
- Alinity m System, Part No. 08N53-002
- Where it went
- Worldwide distribution - US distribution and the countries of Australia, Austria, Belgium, Brazil, Cambodia, Canada, Chile, Colombia, Czech Republic, Egypt, El Salvador, Estonia, Finland, France, Germany, Hong Kong, Ireland, Israel, Italy, Japan, Malawi, Malaysia, Mexico, Montenegro, Morocco, Mozambique, Netherlands, New Zealand, Norway, Pakistan, Poland, Portugal, Romania, Russia, Saudi Arabia, Singapore, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Uganda, United Kingdom, and Vietnam
- How much
- 742 devices
Alinity m System, Part No. 08N53-002
Z-0463-2022 · Class II · reported 2022-01-12 · Terminated
- Why it was recalled
- There is an issue with the installation of updated camera firmware on the system.
- Product
- Alinity m System, Part No. 08N53-002
- Where it went
- Distribution in the United States in CA, DC, GA, KY, IL, MD, MI, MN, MS, NH, NJ, NY, RI, SD, TX, WI OUS distribution to Australia, Cambodia, Canada, Columbia, France, Germany, Israel, Italy, Malaysia, Mozambique, Portugal, South Africa, Spain, Switzerland, Taiwan, United Kingdom, and Vietnam
- How much
- 74 devices
Class I
Alinity m SARS-CoV-2 Amp Kit (Non-US Assay) and Alinity m SARS-CoV-2 Application Specification File. in vitro
Z-0007-2022 · Class I · reported 2021-10-20 · Terminated
- Why it was recalled
- There is a potential for false positive results.
- Product
- Alinity m SARS-CoV-2 Amp Kit (Non-US Assay) and Alinity m SARS-CoV-2 Application Specification File. in vitro diagnostic
- Where it went
- Worldwide Distribution. US Nationwide, AUSTRALIA, AUSTRIA, BELGIUM, BRAZIL, CANADA, COLOMBIA, CZECH REPUBLIC, ESTONIA, FINLAND, FRANCE, GERMANY, HONG KONG, IRELAND, ISRAEL, ITALY, JAPAN, MALAYSIA, MONTENEGRO, NETHERLANDS, NEW ZEALAND, NORWAY, POLAND, PORTUGAL, ROMANIA, SAUDI ARABIA, SINGAPORE, SLOVENIA, SOUTH AFRICA, SOUTH KOREA, SPAIN, SWEDEN, SWITZERLAND, TAIWAN, THAILAND, UNITED KINGDOM, and VIETNAM.
- How much
- 11408 units
Class I
Alinity m Resp-4-Plex AMP Kit (Non-US Assay) and Alinity m Resp-4-Plex Application Specification File. in vitr
Z-0008-2022 · Class I · reported 2021-10-20 · Terminated
- Why it was recalled
- There is a potential for false positive results.
- Product
- Alinity m Resp-4-Plex AMP Kit (Non-US Assay) and Alinity m Resp-4-Plex Application Specification File. in vitro diagnostic
- Where it went
- Worldwide Distribution. US Nationwide, AUSTRALIA, AUSTRIA, BELGIUM, BRAZIL, CANADA, COLOMBIA, CZECH REPUBLIC, ESTONIA, FINLAND, FRANCE, GERMANY, HONG KONG, IRELAND, ISRAEL, ITALY, JAPAN, MALAYSIA, MONTENEGRO, NETHERLANDS, NEW ZEALAND, NORWAY, POLAND, PORTUGAL, ROMANIA, SAUDI ARABIA, SINGAPORE, SLOVENIA, SOUTH AFRICA, SOUTH KOREA, SPAIN, SWEDEN, SWITZERLAND, TAIWAN, THAILAND, UNITED KINGDOM, and VIETNAM.
- How much
- 5855 units
Class I
Alinity m SARS-CoV-2 Amp Kit (Emergency Use Authorization, US Assay) and Alinity m SARS-CoV-2 Application Spec
Z-0004-2022 · Class I · reported 2021-10-20 · Terminated
- Why it was recalled
- There is a potential for false positive results.
- Product
- Alinity m SARS-CoV-2 Amp Kit (Emergency Use Authorization, US Assay) and Alinity m SARS-CoV-2 Application Specification File. in vitro diagnostic
- Where it went
- Worldwide Distribution. US Nationwide, AUSTRALIA, AUSTRIA, BELGIUM, BRAZIL, CANADA, COLOMBIA, CZECH REPUBLIC, ESTONIA, FINLAND, FRANCE, GERMANY, HONG KONG, IRELAND, ISRAEL, ITALY, JAPAN, MALAYSIA, MONTENEGRO, NETHERLANDS, NEW ZEALAND, NORWAY, POLAND, PORTUGAL, ROMANIA, SAUDI ARABIA, SINGAPORE, SLOVENIA, SOUTH AFRICA, SOUTH KOREA, SPAIN, SWEDEN, SWITZERLAND, TAIWAN, THAILAND, UNITED KINGDOM, and VIETNAM.
- How much
- 60563 units
Class I
Alinity m SARS-CoV-2 Amp Kit (Non-US Assay) and Alinity m SARS-CoV-2 Application Specification File. in vitro
Z-0006-2022 · Class I · reported 2021-10-20 · Terminated
- Why it was recalled
- There is a potential for false positive results.
- Product
- Alinity m SARS-CoV-2 Amp Kit (Non-US Assay) and Alinity m SARS-CoV-2 Application Specification File. in vitro diagnostic
- Where it went
- Worldwide Distribution. US Nationwide, AUSTRALIA, AUSTRIA, BELGIUM, BRAZIL, CANADA, COLOMBIA, CZECH REPUBLIC, ESTONIA, FINLAND, FRANCE, GERMANY, HONG KONG, IRELAND, ISRAEL, ITALY, JAPAN, MALAYSIA, MONTENEGRO, NETHERLANDS, NEW ZEALAND, NORWAY, POLAND, PORTUGAL, ROMANIA, SAUDI ARABIA, SINGAPORE, SLOVENIA, SOUTH AFRICA, SOUTH KOREA, SPAIN, SWEDEN, SWITZERLAND, TAIWAN, THAILAND, UNITED KINGDOM, and VIETNAM.
- How much
- 71314 units
Class I
Alinity m Resp-4-Plex AMP Kit (Emergency Use Authorization, US Assay) and Alinity m Resp-4-Plex Application Sp
Z-0005-2022 · Class I · reported 2021-10-20 · Terminated
- Why it was recalled
- There is a potential for false positive results.
- Product
- Alinity m Resp-4-Plex AMP Kit (Emergency Use Authorization, US Assay) and Alinity m Resp-4-Plex Application Specification File. in vitro diagnostic
- Where it went
- Worldwide Distribution. US Nationwide, AUSTRALIA, AUSTRIA, BELGIUM, BRAZIL, CANADA, COLOMBIA, CZECH REPUBLIC, ESTONIA, FINLAND, FRANCE, GERMANY, HONG KONG, IRELAND, ISRAEL, ITALY, JAPAN, MALAYSIA, MONTENEGRO, NETHERLANDS, NEW ZEALAND, NORWAY, POLAND, PORTUGAL, ROMANIA, SAUDI ARABIA, SINGAPORE, SLOVENIA, SOUTH AFRICA, SOUTH KOREA, SPAIN, SWEDEN, SWITZERLAND, TAIWAN, THAILAND, UNITED KINGDOM, and VIETNAM.
- How much
- 8469 units
Vysis CLL FISH Probe Kit with the following components: Vysis LSI p53 SpectrumOrange/ATM, SpectrumGreen and LS
Z-2576-2021 · Class II · reported 2021-10-06 · Terminated
- Why it was recalled
- Potential for Vysis CLL FISH Probe Kits not detecting 13q deletions in known positive patient samples.
- Product
- Vysis CLL FISH Probe Kit with the following components: Vysis LSI p53 SpectrumOrange/ATM, SpectrumGreen and LSI D13S319, SpectrumOrange/ 13q34, SpectrumAqua/CEP 12 SpectrumGreen Probes
- Where it went
- Worldwide distribution - US Nationwide distribution in the states of AZ, CA, FL, GA, IL, IN, KY, MI, MN, MA, NC, NJ, NM, NY, OH, PA, TN, TX, UT, VA, VT, WA, WI and the countries of Australia, Belgium, Brazil, Canada, China, Costa Rica, Czech Republic, Estonia, Germany, Hong Kong, Israel, Italy, Kazakhstan, Netherlands, Philippines, Poland, Saudi Arabia, Slovenia, South Africa, South Korea, Spain, United Kingdom, Uruguay.
- How much
- 186 units
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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