Beckman Coulter

Reports per year

Source: FDA adverse event reports by year received, 2011–2025. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.

Top device categories

• Counter, Differential CellGKZ10,206
• Analyzer, Chemistry (Photometric, Discrete), For Clinical UseJJE6,947
• Immunoassay Method, Troponin SubunitMMI1,672
• Electrode, Ion Specific, SodiumJGS218
• Enzyme Linked Immunoabsorbent Assay, Toxoplasma GondiiLGD161
• Diluent, Blood CellGIF129
• Reagent, Coronavirus SerologicalQKO98
• System, Test, Human Chorionic GonadotropinDHA73
• Gram Negative Identification PanelLQM70
• Radioimmunoassay, Thyroid-Stimulating HormoneJLW67

Recent recalls

• 2026-04-22Open, ClassifiedNonconforming Material/Component

  Access Total T4 Calibrator, Catalog No. 33805

  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.

• 2026-04-08Open, ClassifiedUnder Investigation by firm

  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.

  Due to manufacturing issue (incorrectly processing) with in vitro multidrug resistant test.

• 2026-04-03Open, ClassifiedProcess control

  MicroScan Neg MIC 3J REF C54814

  Due to a manufacturing issue - missing a drug in well 4/4 but contain double the amount of antibiotics

• 2026-03-20Open, ClassifiedMaterial/Component Contamination

  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.

  Due to the likely presence of contamination in well(s).

• 2026-02-02Open, ClassifiedSoftware change control

  CellMek SPS Sample Preparation System, REF: C44603, with software

  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.

• 2026-01-30Open, ClassifiedUnder Investigation by firm

  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.

  Due to specific lots of diluents contributing to elevated platelet Daily Checks background counts cycle with use with analyzers.

• 2026-01-21Open, ClassifiedDevice Design

  The LDL-Cholesterol assay is comprised of two distinct phases. In phase one a unique detergent solubilizes cholesterol from non-LDL- lipoprotein particles. This cholesterol is consumed by cholesterol esterase, cholesterol oxidase, peroxidase and 4- aminoantipyrine to generate a colorless end product. In phase two a second detergent in reagent 2 releases cholesterol from the LDL lipoproteins. This cholesterol reacts with cholesterol esterase, cholesterol oxidase and a chromogen system to yield a blue color complex which can be measured bichromatically at 540/660nm. The resulting increase in absorbance is directly proportional to the LDL-C concentration in the sample.

  Beckman Coulter identified that LDL Cholesterol OSR6x96 is not meeting the performance claim listed in the Instructions for Use (IFU). LDL Cholesterol reagent showed clinically significant interference due to triglyceride concentration up to 1500 mg/dL may cause a maximum positive bias of up to 28.8% in low LDL Cholesterol samples (concentration 80 mg/dL) and up to 11.02% in high LDL Cholesterol samples (concentration 160mg/dL).

• 2026-01-06Open, ClassifiedDevice Design

  Beckman Coulter UniCel Dxl 600, Part numbers: A71460, A71461, A30260; Immunoassay Method, Troponin Subunit

  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.

• 2026-01-06Open, ClassifiedDevice Design

  Beckman Coulter UniCel Dxl 800, Part numbers: 973100, A71456, A71457, A25288; Immunoassay Method, Troponin Subunit

  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.

• 2025-12-23Open, ClassifiedNonconforming Material/Component

  BECKMAN COULTER BICARBONATE REF: OSR6137 OSR6237 OSR6637 OSR6x37 Bicarbonate is a system reagent for the quantitative determination of Bicarbonate in human serum and plasma on Beckman Coulter AU analyzers.

  Bicarbonate reagent may generate falsely high Bicarbonate results due to interference with Lactate Dehydrogenase (LDH) in the test sample.