Beckman Coulter Inc.

Reports per year

Source: FDA adverse event reports by year received, 2003–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.

Top device categories

• Analyzer, Chemistry (Photometric, Discrete), For Clinical UseJJE5,134
• Immunoassay Method, Troponin SubunitMMI1,285
• Counter, Differential CellGKZ891
• Electrode, Ion Specific, SodiumJGS397
• Glucose Oxidase, GlucoseCGA243
• System, Test, Rheumatoid FactorDHR208
• System, Test, Human Chorionic GonadotropinDHA176
• Visual, Pregnancy Hcg, Prescription UseJHI105
• Analyzer, Chemistry (Sequential Multiple, Continuous Flow) Clinical UseJJC102
• Enzyme Linked Immunoabsorbent Assay, Toxoplasma GondiiLGD89

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.

• 2026-01-06Open, 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.

• 2025-12-09Open, ClassifiedProcess design

  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

  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.

• 2025-11-18Open, ClassifiedUnder Investigation by firm

  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.

  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.