Beckman Coulter Inc.

Reports per year

Source: FDA adverse event reports by year received, 2003–2026. Reporting paused twice in 2026 during FDA reporting-system changes and has since resumed.

Top device categories

• Analyzer, Chemistry (Photometric, Discrete), For Clinical UseJJE5,149
• 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

• 2026-08-17Open, ClassifiedSoftware design (manufacturing process)

  Beckman Coulter DxC 500i Clinical Analyzer Modules using software version 1.5 or lower: 1) DxC 500 AU Module w/ISE, DxC 500i, Part Number C63522; 2) DxC 500 AU Module, DxC 500i, Part Number C63521; 3) Access 2 Module, DxC 500i, Part Number C13252; DxC 500 AU Clinical Chemistry Analyzers

  a software defect in which the Parameter Package (PP) import logic overwrites all predefined calculated test rules, including those previously modified by the user, upon import of a new Parameter Package version. As a result, usercustomized calculated test rules revert silently to their default expressions, potentially generating erroneous patient test results without an explicit error notification. The issue affects instruments running software version 1.5 or lower and only occurs when a new Parameter Package is imported to a system that already has an existing Parameter Package onboard; new installations are not affected.

• 2026-08-17Open, ClassifiedSoftware design (manufacturing process)

  Beckman Coulter DxC 500 AU Clinical Analyzer Modules using software version 1.5 or lower: 1) AU w/out ISE, Part Number C63519; 2) AU w/ISE, Part Number C63520; DxC 500 AU Clinical Chemistry Analyzers

  a software defect in which the Parameter Package (PP) import logic overwrites all predefined calculated test rules, including those previously modified by the user, upon import of a new Parameter Package version. As a result, usercustomized calculated test rules revert silently to their default expressions, potentially generating erroneous patient test results without an explicit error notification. The issue affects instruments running software version 1.5 or lower and only occurs when a new Parameter Package is imported to a system that already has an existing Parameter Package onboard; new installations are not affected.

• 2026-08-05Open, ClassifiedSoftware Design Change

  REF # D23352, MicroScan LabPro V5.03 Panel Update 11 (US), Electronic installed on the following instruments: - B1018-280 MicroScan autoSCAN-4 Instrument - B1018-283 MicroScan WalkAway-40 plus Instrument - B1018-284 MicroScan WalkAway-96 plus Instrument - B1018-440 DxM-1040 MicroScan WalkAway Instrument - B1018-496 DxM-1096 MicroScan WalkAway Instrument

  Analyzers contain incorrect algorithms which may affect antimicrobial susceptibility test results, leading to false susceptibility classifications."

• 2026-08-05Open, ClassifiedSoftware Design Change

  REF # D23354, MicroScan LabPro V5.03 Panel Update 11 DVD Kit (US) on the following instruments: - B1018-280 MicroScan autoSCAN-4 Instrument - B1018-283 MicroScan WalkAway-40 plus Instrument - B1018-284 MicroScan WalkAway-96 plus Instrument - B1018-440 DxM-1040 MicroScan WalkAway Instrument - B1018-496 DxM-1096 MicroScan WalkAway Instrument

  Analyzers contain incorrect algorithms which may affect antimicrobial susceptibility test results, leading to false susceptibility classifications."

• 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.