Beckman Coulter Inc.: 330 FDA recall reports
Every medical device recall the FDA has published for Beckman Coulter Inc.. The fault, and how the agency graded it.
330Reports
5Class I
103Ongoing
2026-04-29Most 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.
Access Total T4 Calibrator, Catalog No. 33805
Z-1922-2026 · Class II · reported 2026-04-29 · Ongoing
- Why it was recalled
- Beckman Coulter has identified that Access Total T4 Calibrator lots (PN 33805) exhibit a negative bias on DxI 600/800 instruments, with slopes outside product specifications. A false low patient result could cause a patient to undergo unnecessary additional diagnostic testing. A patient may be treated for a disorder not present or receive delayed treatment for hyperthyroidism. For a pregnant patient being monitored for thyroid hormone supplementation, incorrect treatment or dose may be used. A delayed patient results could cause repeat blood draw with associated complications.
- Product
- Access Total T4 Calibrator, Catalog No. 33805
- Where it went
- Worldwide distribution - US Nationwide and the countries of Argentina, Austria, Bangladesh, Bolivia (Plurinational State of), Bosnia and Herzegovina, Brazil, Canada, China, C¿te d'Ivoire, Croatia, Czechia, Denmark, Egypt, El Salvador, Ethiopia, Georgia, Germany, Greece, Hong Kong, India, Indonesia, Ireland, Italy, Japan, Kazakhstan, Korea, Republic of, Kosovo, Lebanon, Libya, Malawi, Mexico, Myanmar, Nepal, Netherlands, New Zealand, Nigeria, North Macedonia, Pakistan, Panama, Peru, Philippines, Poland, Portugal, Puerto Rico, Qatar, Romania, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, Somalia, Spain, Switzerland, Taiwan, Province of China, Thailand, Turkey, United Arab Emirates, Uzbekistan, Viet Nam, Yemen.
- How much
- 2068 US, 2830 OUS
MicroScan Neg MIC 3J REF C54814
Z-1772-2026 · Class II · reported 2026-04-15 · Ongoing
- Why it was recalled
- Due to a manufacturing issue - missing a drug in well 4/4 but contain double the amount of antibiotics
- Product
- MicroScan Neg MIC 3J REF C54814
- Where it went
- International distribution in the country of Japan.
- How much
- 688 boxes (20 panels per box)
MicroScan Neg Multidrug Resistant MIC 1 REF C32368 UDI-DI code: 15099590720568 Intended Use- For use with
Z-1794-2026 · Class II · reported 2026-04-15 · Ongoing
- Why it was recalled
- Due to manufacturing issue (incorrectly processing) with in vitro multidrug resistant test.
- Product
- MicroScan Neg Multidrug Resistant MIC 1 REF C32368 UDI-DI code: 15099590720568 Intended Use- For use with MicroScan Dried Gram Negative MIC/Combo Panels and Dried Gram Negative Breakpoint Combo Panels. MicroScan panels are designed for use in determining antimicrobial agent susceptibility and/or identification to the species level of aerobic and facultatively anaerobic gram-negative bacilli.
- Where it went
- International distribution to the country of Poland.
- How much
- 3 boxes
MicroScan Neg MIC 56 REF C42464 UDI-DI code: 15099590731212 MicroScan panels are designed for use in deter
Z-1609-2026 · Class II · reported 2026-04-01 · Ongoing
- Why it was recalled
- Due to the likely presence of contamination in well(s).
- Product
- MicroScan Neg MIC 56 REF C42464 UDI-DI code: 15099590731212 MicroScan panels are designed for use in determining antimicrobial agent susceptibility and/or identification to the species level of aerobic and facultatively anaerobic gram-negative bacilli.
- Where it went
- U.S. Nationwide distribution in the states of CA, CO, IN, MA, MD, MN, MO, NC, NJ, OK, PA, and TX.
- How much
- 685 boxes
COULTER DxH Diluent, REF 628017 COULTER DxH ECO Diluent REF C67250 For use as an isotonic buffered diluent
Z-1221-2026 · Class II · reported 2026-02-11 · Ongoing
- Why it was recalled
- Due to specific lots of diluents contributing to elevated platelet Daily Checks background counts cycle with use with analyzers.
- Product
- COULTER DxH Diluent, REF 628017 COULTER DxH ECO Diluent REF C67250 For use as an isotonic buffered diluent in conjunction with a cyanide-free lytic agent for counting and sizing blood cells on all UniCel DxH Coulter Cellular Analysis Systems. For use as a rinsing agent on the UniCel DxH Slidemaker Stainers. For use as a diluent in conjunction with DxH ECO Cell Lyse for counting and sizing blood cells. For use as a rinsing agent.
- Where it went
- Worldwide - U.S. Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, DC, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PA, Puerto Rico, RI, SC, SD, TN, TX, UT, VA, WA, WI, and WV. The countries of Argentina, Canada, Chile, Mexico, Saint Kitts and Nevis, Trinidad and Tobago, and Viet Nam.
- How much
- 76,098 units (US-61843 and OUS-14255)
CellMek SPS Sample Preparation System, REF: C44603, with software
Z-1235-2026 · Class II · reported 2026-02-11 · Ongoing
- Why it was recalled
- Sample preparation system designed to automate staining, lysing, cell washing has a software error that causes samples to be dispensed close to or touching tube bottoms, which could dislodge fluid line, result in sample loss, spillage, make instrument inoperable and will lead to unintentional removal of 60-100 microliters from final sample, may lead to incorrect diagnosis or patient management.
- Product
- CellMek SPS Sample Preparation System, REF: C44603, with software
- Where it went
- Worldwide - US Nationwide distribution in the states of MO, WA, MA, IL, AL, OR, IL and the countries of AB, BE, ES, FR, NL, ON, DE, AT, VIC, AU, GB, SK, MX, CH.
- How much
- 50
Beckman Coulter UniCel Dxl 600, Part numbers: A71460, A71461, A30260; Immunoassay Method, Troponin Subunit
Z-1025-2026 · Class II · reported 2026-01-14 · Ongoing
- Why it was recalled
- Beckman Coulter has determined that, due to a potential communication issue, the analyzers listed above may not successfully restart following a standard shutdown, even after multiple attempts. If this issue occurs, the instrument will be unable to complete initialization and transition to Ready mode and the instrument will not process patient samples, QCs or calibrators. This causes delayed results.
- Product
- Beckman Coulter UniCel Dxl 600, Part numbers: A71460, A71461, A30260; Immunoassay Method, Troponin Subunit
- Where it went
- Worldwide Distribution: US (nationwide) and OUS (foreign) to countries of: Albania, Algeria, Argentina, Australia, Austria, Azerbaijan, Bahrain, Bangladesh, Belarus, Belgium, Bosnia and Herzegovina, Botswana, Brazil, Bulgaria, Cabo Verde, Canada, Chile, China, Costa Rica, Croatia, Czechia, Denmark, Dominican Republic, Egypt, El Salvador, Eswatini, Ethiopia, France, Georgia, Germany, Ghana, Gibraltar, Greece, Hong Kong, Hungary, India Indonesia, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Korea, Republic of, Kosovo, Kuwait, Kyrgyzstan, Lebanon, Libya, Lithuania, Malaysia, Mayotte, Mexico, Moldova, Republic of, Morocco, Myanmar, Nepal, Netherlands, New Zealand, Nigeria, North Macedonia, Oman, Pakistan, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Puerto Rico, Qatar, Romania, Russian Federation, San Marino, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Province of China, Thailand, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom of Great Britain and Northern Ireland, Viet Nam, and Zimbabwe.
- How much
- 1272 units
Beckman Coulter UniCel Dxl 800, Part numbers: 973100, A71456, A71457, A25288; Immunoassay Method, Troponin S
Z-1026-2026 · Class II · reported 2026-01-14 · Ongoing
- Why it was recalled
- Beckman Coulter has determined that, due to a potential communication issue, the analyzers listed above may not successfully restart following a standard shutdown, even after multiple attempts. If this issue occurs, the instrument will be unable to complete initialization and transition to Ready mode and the instrument will not process patient samples, QCs or calibrators. This causes delayed results.
- Product
- Beckman Coulter UniCel Dxl 800, Part numbers: 973100, A71456, A71457, A25288; Immunoassay Method, Troponin Subunit
- Where it went
- Worldwide Distribution: US (nationwide) and OUS (foreign) to countries of: Albania, Algeria, Argentina, Australia, Austria, Azerbaijan, Bahrain, Bangladesh, Belarus, Belgium, Bosnia and Herzegovina, Botswana, Brazil, Bulgaria, Cabo Verde, Canada, Chile, China, Costa Rica, Croatia, Czechia, Denmark, Dominican Republic, Egypt, El Salvador, Eswatini, Ethiopia, France, Georgia, Germany, Ghana, Gibraltar, Greece, Hong Kong, Hungary, India Indonesia, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Korea, Republic of, Kosovo, Kuwait, Kyrgyzstan, Lebanon, Libya, Lithuania, Malaysia, Mayotte, Mexico, Moldova, Republic of, Morocco, Myanmar, Nepal, Netherlands, New Zealand, Nigeria, North Macedonia, Oman, Pakistan, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Puerto Rico, Qatar, Romania, Russian Federation, San Marino, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Province of China, Thailand, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom of Great Britain and Northern Ireland, Viet Nam, and Zimbabwe.
- How much
- 6457 units
Access 2 Reaction Vessels, individual, disposable, plastic tubes used to process patient, quality control and
Z-0889-2026 · Class II · reported 2025-12-17 · Ongoing
- Why it was recalled
- It has been determined that certain lots of Access 2 Reaction Vessels may contain manufacturing deformities. The bottom (round end) of the Reaction Vessel may have a small protrusion or hair like deformity. This could cause causing instrument errors (e.g., pipetting, rake, wash carousel errors) that could delay patient results.
- Product
- Access 2 Reaction Vessels, individual, disposable, plastic tubes used to process patient, quality control and calibration samples on the Access 2 Immunoassay system, Catalog Number 81901
- Where it went
- US Nationwide. Global Distribution.
- How much
- 38,225 untis
DxFLEX Flow Cytometer Catalog Number C78500 UDI-DI code: 15099590754013 The DxFLEX Flow Cytometer is inten
Z-0541-2026 · Class II · reported 2025-11-26 · Ongoing
- Why it was recalled
- Due to a software error code that crashes during acquisition on patient sample when running customer defined acquisition protocol. This may lead to delayed patient results.
- Product
- DxFLEX Flow Cytometer Catalog Number C78500 UDI-DI code: 15099590754013 The DxFLEX Flow Cytometer is intended for use as an in vitro diagnostic device for immunophenotyping up to ten fluorescent detection channels using three lasers (488 nm, 638 nm and 405 nm) and two light scatter detection channels. It is intended for use with in vitro diagnostic (IVD) assays and software that are indicated for use with the instrument.
- Where it went
- Worldwide - U.S. Nationwide distribution in the states of CA, CT, FL, IL, NY, OH, OR, TN, and TX. The country of India.
- How much
- 25 units
Beckman Coulter UniCel DxI 600, Part Numbers: A71460, A30260; Photometric Chemistry Analyzer
Z-0428-2026 · Class II · reported 2025-11-12 · Ongoing
- Why it was recalled
- An internal investigation has determined that due to defective sub-components within the gantry assembly, a z-axis CAD movement motion error may occur and cause an analyzer to enter a Not Ready or Paused state, leading to a delay in obtaining results.
- Product
- Beckman Coulter UniCel DxI 600, Part Numbers: A71460, A30260; Photometric Chemistry Analyzer
- Where it went
- Worldwide
- How much
- 80 units
Beckman Coulter UniCel DxI 800, Part Numbers: 973100, A71456; Photometric Chemistry Analyzer
Z-0429-2026 · Class II · reported 2025-11-12 · Ongoing
- Why it was recalled
- An internal investigation has determined that due to defective sub-components within the gantry assembly, a z-axis CAD movement motion error may occur and cause an analyzer to enter a Not Ready or Paused state, leading to a delay in obtaining results.
- Product
- Beckman Coulter UniCel DxI 800, Part Numbers: 973100, A71456; Photometric Chemistry Analyzer
- Where it went
- Worldwide
- How much
- 657 units
SYNCHRON Systems Direct LDL Cholesterol (LDLD) Reagent, REF: 969706
Z-0441-2026 · Class II · reported 2025-11-12 · Ongoing
- Why it was recalled
- Beckman Coulter has identified that there is an increased probability Synchron Systems Direct LDL Cholesterol (LDLD REF 969706) reagent lot M404166 may generate false high results. The issue was discovered internally and confirmed on August 19, 2025 by Beckman Coulter.
- Product
- SYNCHRON Systems Direct LDL Cholesterol (LDLD) Reagent, REF: 969706
- Where it went
- Worldwide - US Nationwide distribution in the states of AL, AR, CA, FL, GA, HI, IA, ID, KS, KY, LA, MA, MD, ME, MI, MO, MS, NC, NE, NJ, NM, NY, OH, OK, OR, PA, PR, QC, SC, TX, WA, WV and the country of Canada.
- How much
- 2,932 units
CellMek SPS Sample Preparation System, REF: C44603. Software versions 2.2.122.0 and prior, and Instructions fo
Z-0412-2026 · Class II · reported 2025-11-05 · Ongoing
- Why it was recalled
- Automated pipetting, diluting and specimen processing workstations for flow cytometric analysis device instructions for use list incorrect dead volumes: Cassette Type/List volume/correct volume, B/750/1582 microliters, and E/1300/2093 microliters. Device software does not rock Cassette E, used with 15mmX92mm Sarstedt tubes. May lead to incorrect diagnosis or error in patient management/treatment.
- Product
- CellMek SPS Sample Preparation System, REF: C44603. Software versions 2.2.122.0 and prior, and Instructions for Use (IFU) revisions AD and prior. These CellMek devices include Cassette E.
- Where it went
- Worldwide - US Nationwide distribution in the states of AL, AR, FL, IL, IN, MA, ME, MI, MN, MO, NY, OR, TN, UT, WA and the countries Australia, Austria, Belgium, Brazil, Canada, China, France, Germany, Greece, Hong Kong, Israel, Italy, Japan, Korea, Republic of, Mexico, Morocco, Netherlands, Poland, Portugal, Puerto Rico, South Africa, Spain, Switzerland, United Kingdom of Great Britain and Northern Ireland.
- How much
- 108 units
DxI 9000 Access Immunoassay Analyzer, Part Number C11137
Z-0216-2026 · Class II · reported 2025-10-29 · Ongoing
- Why it was recalled
- Beckman Coulter has confirmed a software anomaly on DxI 9000 Access Immunoassay Analyzer and the DxC 500i Clinical Analyzer that may prevent correct application of user-specified manual dilution factors when ordering additional tests for samples already "In Progress" using the same "Sample ID number". This can lead to false low or high patient results and potential delays in reporting, risking erroneous diagnoses if undetected.
- Product
- DxI 9000 Access Immunoassay Analyzer, Part Number C11137
- Where it went
- Worldwide - US Nationwide distribution.
- How much
- 571 units
DxC 500i Clinical Analyzer Modules, DxC 500 AU Module w/ISE, DxC 500i (Part Number C63522), DxC 500 AU Module,
Z-0215-2026 · Class II · reported 2025-10-29 · Ongoing
- Why it was recalled
- Beckman Coulter has confirmed a software anomaly on DxI 9000 Access Immunoassay Analyzer and the DxC 500i Clinical Analyzer that may prevent correct application of user-specified manual dilution factors when ordering additional tests for samples already "In Progress" using the same "Sample ID number". This can lead to false low or high patient results and potential delays in reporting, risking erroneous diagnoses if undetected.
- Product
- DxC 500i Clinical Analyzer Modules, DxC 500 AU Module w/ISE, DxC 500i (Part Number C63522), DxC 500 AU Module, DxC 500i (Part Number C63521), and Access 2 Module, DxC 500i (Part Number C13252)
- Where it went
- Worldwide - US Nationwide distribution.
- How much
- 160 units
SYNCHRON Systems Phosphorus (PHOSm) Reagent REF: 467868 For In Vitro Diagnostic Use, Rx Only.
Z-0071-2026 · Class II · reported 2025-10-15 · Ongoing
- Why it was recalled
- Specific SYNCHRON Systems Modular Chemistry Phosphorus (PHOSm REF 467868) reagent lots may fail calibration before the lot expiration date which causes a delay in obtaining patient results.
- Product
- SYNCHRON Systems Phosphorus (PHOSm) Reagent REF: 467868 For In Vitro Diagnostic Use, Rx Only.
- Where it went
- US: AL KY LA MA MD MS NC NE NJ NY OK PA TX WA WV OUS: Canada Mexico Singapore
- How much
- 2146 units
DxC 500 AU Module w/ISE, DxC 500i, With ISE, REF: C63522 and DxC 500 AU Module, DxC 500i, Without ISE, REF: C6
Z-0032-2026 · Class II · reported 2025-10-08 · Ongoing
- Why it was recalled
- On a clinical analyzer, when ordering a Clinical Chemistry (CC) combination test simultaneously with an Immunoassay (IA) test, if the IA test is processed between the CC tests, CC sample status will remain In Progress with no errors, may cause processing delays.
- Product
- DxC 500 AU Module w/ISE, DxC 500i, With ISE, REF: C63522 and DxC 500 AU Module, DxC 500i, Without ISE, REF: C6352; part of the DxC 500i Clinical Analyzer
- Where it went
- Internationally distribution to the countries of Poland, India, Dominican Republic, Lebanon, Italy, Brazil, El Salvador, Saudi Arabia, Germany, France, Nepal, Canada, Chile, Spain, Malaysia, Switzerland, Morocco, Philippines, Curacao, Qatar, United Arab Emirates, Hungary, Czechia, Oman, New Zealand, Thailand, Indonesia, Algeria, United Kingdom of Great Britain and Northern Ireland, Namibia, Turkey, Republic of Korea
- How much
- 116
UniCel DxH 800 COULTER Cellular Analysis System, configured with the Led HGB Photometer REFs:B24802, 629029,
Z-2574-2025 · Class II · reported 2025-09-24 · Ongoing
- Why it was recalled
- Hematology analyzers configured with HGB photometers may result in erroneously high hemoglobin (HGB) results on samples with elevated white blood cell (WBC) counts.
- Product
- UniCel DxH 800 COULTER Cellular Analysis System, configured with the Led HGB Photometer REFs:B24802, 629029, B63322
- Where it went
- Worldwide - US Nationwide distribution including in the states of AL, AZ, CA, CT, FL, GA, IA, ID, IL, IN, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NE, NJ, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, VA, WA, WI, WV and the countries of Algeria, Argentina, Australia, Bahrain, Bosnia and Herzegovina, Brazil, Canada, Chile, China, Croatia, Czechia, Egypt, France, Germany, Ghana, Greece, Hong Kong, Hungary, India, Indonesia, Israel, Italy, Japan, Jordan, Kenya, Korea Republic of, Kuwait, Kyrgyzstan, Libya, Lithuania, Mexico, Nepal, Netherlands, New Zealand, North Macedonia, Oman, Pakistan, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Puerto Rico, Romania, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, Spain, Switzerland, Taiwan, Province of China, Thailand, Trinidad and Tobago, United Arab Emirates, United Kingdom of Great Britain and Northern Ireland, United States of America, Uruguay, Vietnam.
- How much
- N/A
UniCel DxH 900 COULTER Cellular Analysis System, configured with the Led HGB Photometer REF: C11478
Z-2572-2025 · Class II · reported 2025-09-24 · Ongoing
- Why it was recalled
- Hematology analyzers configured with HGB photometers may result in erroneously high hemoglobin (HGB) results on samples with elevated white blood cell (WBC) counts.
- Product
- UniCel DxH 900 COULTER Cellular Analysis System, configured with the Led HGB Photometer REF: C11478
- Where it went
- Worldwide - US Nationwide distribution including in the states of AL, AZ, CA, CT, FL, GA, IA, ID, IL, IN, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NE, NJ, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, VA, WA, WI, WV and the countries of Algeria, Argentina, Australia, Bahrain, Bosnia and Herzegovina, Brazil, Canada, Chile, China, Croatia, Czechia, Egypt, France, Germany, Ghana, Greece, Hong Kong, Hungary, India, Indonesia, Israel, Italy, Japan, Jordan, Kenya, Korea Republic of, Kuwait, Kyrgyzstan, Libya, Lithuania, Mexico, Nepal, Netherlands, New Zealand, North Macedonia, Oman, Pakistan, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Puerto Rico, Romania, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, Spain, Switzerland, Taiwan, Province of China, Thailand, Trinidad and Tobago, United Arab Emirates, United Kingdom of Great Britain and Northern Ireland, United States of America, Uruguay, Vietnam.
- How much
- N/A
UniCel DxH 690T COULTER Cellular Analysis System, configured with the Led HGB Photometer REF: C34520
Z-2573-2025 · Class II · reported 2025-09-24 · Ongoing
- Why it was recalled
- Hematology analyzers configured with HGB photometers may result in erroneously high hemoglobin (HGB) results on samples with elevated white blood cell (WBC) counts.
- Product
- UniCel DxH 690T COULTER Cellular Analysis System, configured with the Led HGB Photometer REF: C34520
- Where it went
- Worldwide - US Nationwide distribution including in the states of AL, AZ, CA, CT, FL, GA, IA, ID, IL, IN, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NE, NJ, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, VA, WA, WI, WV and the countries of Algeria, Argentina, Australia, Bahrain, Bosnia and Herzegovina, Brazil, Canada, Chile, China, Croatia, Czechia, Egypt, France, Germany, Ghana, Greece, Hong Kong, Hungary, India, Indonesia, Israel, Italy, Japan, Jordan, Kenya, Korea Republic of, Kuwait, Kyrgyzstan, Libya, Lithuania, Mexico, Nepal, Netherlands, New Zealand, North Macedonia, Oman, Pakistan, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Puerto Rico, Romania, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, Spain, Switzerland, Taiwan, Province of China, Thailand, Trinidad and Tobago, United Arab Emirates, United Kingdom of Great Britain and Northern Ireland, United States of America, Uruguay, Vietnam.
- How much
- N/A
UniCel DxH 600 COULTER Cellular Analysis System, configured with the Led HGB Photometer REF:B23858
Z-2575-2025 · Class II · reported 2025-09-24 · Ongoing
- Why it was recalled
- Hematology analyzers configured with HGB photometers may result in erroneously high hemoglobin (HGB) results on samples with elevated white blood cell (WBC) counts.
- Product
- UniCel DxH 600 COULTER Cellular Analysis System, configured with the Led HGB Photometer REF:B23858
- Where it went
- Worldwide - US Nationwide distribution including in the states of AL, AZ, CA, CT, FL, GA, IA, ID, IL, IN, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NE, NJ, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, VA, WA, WI, WV and the countries of Algeria, Argentina, Australia, Bahrain, Bosnia and Herzegovina, Brazil, Canada, Chile, China, Croatia, Czechia, Egypt, France, Germany, Ghana, Greece, Hong Kong, Hungary, India, Indonesia, Israel, Italy, Japan, Jordan, Kenya, Korea Republic of, Kuwait, Kyrgyzstan, Libya, Lithuania, Mexico, Nepal, Netherlands, New Zealand, North Macedonia, Oman, Pakistan, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Puerto Rico, Romania, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, Spain, Switzerland, Taiwan, Province of China, Thailand, Trinidad and Tobago, United Arab Emirates, United Kingdom of Great Britain and Northern Ireland, United States of America, Uruguay, Vietnam.
- How much
- N/A
Access Thyroglobulin assay, a simultaneous one-step immunoenzymatic assay, Catalog Number 33860
Z-2322-2025 · Class II · reported 2025-08-20 · Ongoing
- Why it was recalled
- Access Thyroglobulin reagent lot 439163 may generate erroneously high patient results. Falsely increased Access Thyroglobulin results may lead a physician to pursue unnecessary diagnostic imaging studies and/or inappropriate therapy adjustments in patients being monitored for residual or recurrent thyroid cancer.
- Product
- Access Thyroglobulin assay, a simultaneous one-step immunoenzymatic assay, Catalog Number 33860
- Where it went
- Worldwide - US Nationwide and the countries of Brazil, Canada, Georgia, Italy, Malaysia, Mexico, Philippines, Spain.
- How much
- 453 units
UIBC (Unsaturated Iron Binding Capacity), REF: OSR61205,
Z-2264-2025 · Class II · reported 2025-08-13 · Ongoing
- Why it was recalled
- Beckman Coulter identified that the Unsaturated Iron Binding Capacity (UIBC) assay is not meeting their labeled hemoglobin interference claims of no significant interference (i.e., less than 10%) up to 200 mg/dL hemoglobin as indicated in their instructions for use. Initial internal testing confirmed that samples with low UIBC levels failed the claimed hemolysis interference specifications with reported biases up to -43.6 % UIBC when hemolyzed serum samples contained 200 mg/dL hemoglobin.
- Product
- UIBC (Unsaturated Iron Binding Capacity), REF: OSR61205,
- Where it went
- US: AK, AL, AR, CO, CT, DC, DE, ID, UT OUS: Algeria, Argentina, Australia, Bahrain, Bangladesh, Belarus, Belgium, Bosnia and Herzegovina, Brazil, Bulgaria, Canada, China, Colombia, Costa Rica, Croatia, Czechia, Egypt, El Salvador, Ethiopia, Georgia, Germany, Ghana, Gibraltar, Greece, Hong Kong, Hungary, India, Indonesia, Ireland, Israel, Italy, Jordan, Kazakhstan, Korea, Republic of, Kuwait, Lebanon, Libya, Lithuania, Malaysia, Maldives, Mexico, Morocco, Mozambique, Myanmar, Nepal, Netherlands, Nigeria, North Macedonia, Oman, Pakistan, Panama, Peru, Philippines, Poland, Portugal, Puerto Rico, Qatar, Romania, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, Somalia, South Africa, Spain, Sri Lanka, Sweden, Taiwan, Province of China, Thailand, Tunisia, Turkey, United Arab Emirates, United Kingdom of Great Britain and Northern Ireland, Uzbekistan, Viet Nam, Yemen.
- How much
- 56,696 units
DxI 800 Access Immunoassay Analyzer W/Dual Gantry, Part Number A71457
Z-2267-2025 · Class II · reported 2025-08-13 · Ongoing
- Why it was recalled
- Beckman Coulter has identified that the UniCel DxI 600/800 systems with linear slide PnP gantries running software versions 5.7 and up faced incorrect PnP X-motor current settings where the PnP X-motor current incorrectly resets to 1.5A (instead of the required 2.0A) because the software overwrites the factory setting during installs or upgrades. This anomaly causes increased PnP motion errors which could lead to delays in reporting patient sample results if unnoticed.
- Product
- DxI 800 Access Immunoassay Analyzer W/Dual Gantry, Part Number A71457
- Where it went
- Worldwide distribution - US Nationwide.
- How much
- 1 system
DxI 600 Access Immunoassay Analyzer W/Spot B, Part Number A71460
Z-2271-2025 · Class II · reported 2025-08-13 · Ongoing
- Why it was recalled
- Beckman Coulter has identified that the UniCel DxI 600/800 systems with linear slide PnP gantries running software versions 5.7 and up faced incorrect PnP X-motor current settings where the PnP X-motor current incorrectly resets to 1.5A (instead of the required 2.0A) because the software overwrites the factory setting during installs or upgrades. This anomaly causes increased PnP motion errors which could lead to delays in reporting patient sample results if unnoticed.
- Product
- DxI 600 Access Immunoassay Analyzer W/Spot B, Part Number A71460
- Where it went
- Worldwide distribution - US Nationwide.
- How much
- 177 systems
DxI 800 Access Immunoassay Analyzer W/Spot B, Part Number A71456
Z-2268-2025 · Class II · reported 2025-08-13 · Ongoing
- Why it was recalled
- Beckman Coulter has identified that the UniCel DxI 600/800 systems with linear slide PnP gantries running software versions 5.7 and up faced incorrect PnP X-motor current settings where the PnP X-motor current incorrectly resets to 1.5A (instead of the required 2.0A) because the software overwrites the factory setting during installs or upgrades. This anomaly causes increased PnP motion errors which could lead to delays in reporting patient sample results if unnoticed.
- Product
- DxI 800 Access Immunoassay Analyzer W/Spot B, Part Number A71456
- Where it went
- Worldwide distribution - US Nationwide.
- How much
- 451 systems
DxI 600 Access Immunoassay Analyzer W/Dual Gantry, Part Number A71461
Z-2270-2025 · Class II · reported 2025-08-13 · Ongoing
- Why it was recalled
- Beckman Coulter has identified that the UniCel DxI 600/800 systems with linear slide PnP gantries running software versions 5.7 and up faced incorrect PnP X-motor current settings where the PnP X-motor current incorrectly resets to 1.5A (instead of the required 2.0A) because the software overwrites the factory setting during installs or upgrades. This anomaly causes increased PnP motion errors which could lead to delays in reporting patient sample results if unnoticed.
- Product
- DxI 600 Access Immunoassay Analyzer W/Dual Gantry, Part Number A71461
- Where it went
- Worldwide distribution - US Nationwide.
- How much
- 1 system
UniCel DxI 600 Access Immunoassay Analyzer, Part Number A30260
Z-2269-2025 · Class II · reported 2025-08-13 · Ongoing
- Why it was recalled
- Beckman Coulter has identified that the UniCel DxI 600/800 systems with linear slide PnP gantries running software versions 5.7 and up faced incorrect PnP X-motor current settings where the PnP X-motor current incorrectly resets to 1.5A (instead of the required 2.0A) because the software overwrites the factory setting during installs or upgrades. This anomaly causes increased PnP motion errors which could lead to delays in reporting patient sample results if unnoticed.
- Product
- UniCel DxI 600 Access Immunoassay Analyzer, Part Number A30260
- Where it went
- Worldwide distribution - US Nationwide.
- How much
- 271 systems
UniCel DxI 800 Access Immunoassay Analyzer, Part Number 973100
Z-2266-2025 · Class II · reported 2025-08-13 · Ongoing
- Why it was recalled
- Beckman Coulter has identified that the UniCel DxI 600/800 systems with linear slide PnP gantries running software versions 5.7 and up faced incorrect PnP X-motor current settings where the PnP X-motor current incorrectly resets to 1.5A (instead of the required 2.0A) because the software overwrites the factory setting during installs or upgrades. This anomaly causes increased PnP motion errors which could lead to delays in reporting patient sample results if unnoticed.
- Product
- UniCel DxI 800 Access Immunoassay Analyzer, Part Number 973100
- Where it went
- Worldwide distribution - US Nationwide.
- How much
- 2203 systems
Showing the 30 most recent of 330. 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.
← All device recalls