The Recall Desk

Manufacturer

Beckman Coulter, Inc.

334 recalls in our database name Beckman Coulter, Inc. as the manufacturing or recalling firm.

What the numbers show

Total
334
Critical
0
Severe
6
Most recent
2026-08-26

Of the 334 recalls from Beckman Coulter, Inc. we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 6 (2%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

276–300 of 334

  • ModerateFDA (Devices)·Z-1024-2015·2015-02-04

    Beckman Coulter Uric Acid Assay Recalled Due to NAC Interference

    Beckman Coulter is recalling Uric Acid Assay kits because N-acetyl cysteine administration can cause falsely low test results.

    Product
    Beckman Coulter, Uric Acid Assay, Catalog No. OSR6X98
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0176-2015·2014-11-12

    Beckman Coulter Recalls DxC 600i Analyzer Console PC Due to Error

    Beckman Coulter is recalling the Small Form Factor Console PC for the DxC 600i analyzer because it may experience an 'MFC Exception' error during normal operation.

    Product
    UniCel DxC 600i SYNCHRON Access Clinical Analyzer, Catalog No. A25640, Instructions for Use Part No. A93659AB. Product Usage: The DxI 600i systems are in vitro diagnostic device used for the quantitative, semi-quantitative, or qualitative determination of various analytes con
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0175-2015·2014-11-12

    Beckman Coulter Recalls Access 2 Immunoassay Systems Due to Software Error

    Beckman Coulter is recalling Access 2 Immunoassay Systems because the Small Form Factor Console PC may experience an 'MFC Exception' error during normal operation.

    Product
    Access 2 Immunoassay Systems, Catalog No. 81600N, 386220, Instructions for Use Part No. B14253A. Product Usage: The Access 2 Immunoassay system is an in vitro diagnostic device used for the quantitative, semi-quantitative, or qualitative determination of various analyte conce
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2687-2014·2014-10-01

    Beckman Coulter Recalls Sample Probe Cables for Immunoassay Systems

    Beckman Coulter is recalling sample probe cables for UniCel immunoassay systems because nonconforming units may cause delays in reporting test results.

    Product
    UniCel 600/800 Access Immunoassay Systems are in vitro diagnostic devices used for the quantitative, semi-quantitative, or qualitative determination of various analytes concentrations found in human body fluids. The cables and kits are used in UniCel DxI 600, 800 instruments, and
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2651-2014·2014-09-24

    Beckman Coulter Recalls Coulter DxH Diluent Due to Elevated Platelet Background Counts

    Beckman Coulter is recalling Coulter DxH Diluent because it may cause elevated platelet background counts, resulting in failed Daily Checks on specific Coulter Cellular Analysis Systems.

    Product
    Coulter DxH Diluent, Catalog No. 628017 Blood cell analysis comprises diluting a whole-blood sample with a solution that functions as a diluent. The diluent provides the ability to analyze portions of the diluted blood sample for different blood cell types and the measurement
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1828-2014·2014-07-02

    Beckman Coulter Recalls UniCel DxH 800 and DxH 600 Analysis Systems

    Beckman Coulter is recalling UniCel DxH 800 and DxH 600 systems because optical degradation may delay reporting of specific blood cell results.

    Product
    UniCel DxH 800 Coulter Cellular Analysis System, Part No. 629029, B24465, and B24802. Used for in vitro diagnostic use in screening patient populations found in clinical laboratories.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1829-2014·2014-07-02

    Beckman Coulter Recalls UniCel DxH 600 and DxH 800 Analysis Systems

    Beckman Coulter is recalling UniCel DxH 600 and DxH 800 systems because optical degradation may delay reporting of specific blood cell results.

    Product
    UniCel DxH 600 Coulter Cellular Analysis System, Part No. B23858. Used for in vitro diagnostic use in screening patient populations found in clinical laboratories.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1831-2014·2014-07-02

    Beckman Coulter Recalls UniCel DxH Analysis Systems for Optical Degradation

    Beckman Coulter is recalling UniCel DxH800 and DxH600 systems because optical degradation may delay reporting of specific blood cell results.

    Product
    Coulter DxH Cleaner 10L, Part No. 628023. For use on UniCel DxH Systems for components that come in contact with blood samples.
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1830-2014·2014-07-02

    Beckman Coulter Recalls UniCel DxH Analysis Systems for Optical Defect

    Beckman Coulter is recalling UniCel DxH800 and DxH600 systems because optical degradation may delay reporting of specific blood test results.

    Product
    Coulter DxH Cleaner 5L, Part No. 628022. For use on UniCel DxH Systems for components that come in contact with blood samples.
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1737-2014·2014-06-18

    Beckman Coulter Recalls Ultrasonic Transducer Kits Due to Incorrect Screws

    Beckman Coulter is recalling 82 Ultrasonic Transducer Kits because they may have been assembled with incorrect mounting screws.

    Product
    Ultrasonic Transducer Kits For use with the Access Family of Immunoassay Systems*. *The Access Family of Immunoassay Systems includes the Access 2, UniCel DxI 800 and UniCel DxI 600, UniCel DxC 600i, and the UniCel DxC 880i, UniCel DxC 860i, UniCel DxC 680i, and UniCel DxC 6
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0985-2014·2014-02-26

    Beckman Coulter Recalls UniCel DxI 600 Access Immunoassay System Analyzer

    Beckman Coulter is recalling the UniCel DxI 600 Access Immunoassay System Analyzer because non-conforming bushings may cause incorrect test results.

    Product
    UniCel DxI 600 Access Immunoassay System Analyzer. The Access Immunoassay System is an in vitro diagnostic device used for the quantitative, semi-quantitative or qualitative determination of various analyte concentrations found in human body fluids.
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-0984-2014·2014-02-26

    Beckman Coulter Access 2 Immunoassay System Analyzer Recalled for Non-Conforming Bushings

    Beckman Coulter is recalling three Access 2 Immunoassay System Analyzers because non-conforming bushings may generate incorrect results.

    Product
    Access 2 Immunoassay System Analyzer. The Access Immunoassay System is an in vitro diagnostic device used for the quantitative, semi-quantitative or qualitative determination of various analyte concentrations found in human body fluids.
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-0519-2014·2013-12-25

    Beckman Coulter Recalls Access Immunoassay Reaction Vessels Due to Motion Errors

    Beckman Coulter is recalling Access Immunoassay Reaction Vessels due to intermittent wash carousel motion errors affecting specific lots.

    Product
    Access Immunoassay Systems Reaction Vessels. The Access Immunoassay System is an in vitro diagnostic device used for the quantitative, semi-quantitative or qualitative determination of various analyte concentrations found in human body fluids.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0470-2014·2013-12-18

    Beckman Coulter Recalls LH 750 Hematology Analyzers Due to Optical Degradation

    Beckman Coulter is recalling LH 750 Hematology Analyzers because optical degradation may delay reporting results for specific blood cell counts.

    Product
    Coulter LH 750 Hematology Analyzer, Part No. 6605632, A85570 Product Usage: The Coulter LH 750 Hematology Analyzer is a quantitative, automated hematology analyzer and leukocyte differential counter For In Vitro Diagnostic Use in clinical laboratories. The Coulter¿ LH 750 He
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0471-2014·2013-12-18

    Beckman Coulter Recalls LH 750 and LH 780 Hematology Systems

    Beckman Coulter is recalling LH 750 and LH 780 Hematology Systems because optical degradation may delay reporting results for specific blood cell counts.

    Product
    Coulter LH 780 Hematology Analyzer, Part No. 723585, A90728 Product Usage: Coulter LH 780 Hematology Analyzer is a is a quantitative, automated hematology analyzer and leukocyte differential counter For In Vitro Diagnostic Use in clinical laboratories. The Coulter¿ LH 780 He
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0291-2014·2013-11-20

    Beckman Coulter Recalls Access 2 Immunoassay System Due to Fuse Defect

    Beckman Coulter is recalling the Access 2 Immunoassay System because the fuses may have the wrong amperage.

    Product
    Access 2 Immunoassay System, Part Number: 81600N The Access Immunoassay System is an in vitro diagnostic device used for the quantitative, semi-quantitative or qualitative determination of various analyte concentrations found in human body fluids.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0147-2014·2013-11-13

    Beckman Coulter Recalls UniCel DxH 800 and DxH 600 Hematology Analyzers

    Beckman Coulter is recalling 1,025 UniCel DxH 800 and DxH 600 hematology analyzers because specific check valves may fail, potentially causing air or liquid leaks.

    Product
    UniCel DxH 800 and DxH 600 Coulter Cellular Analysis Systems The UniCel DxH 800/DxH 600 analyzers are quantitative, multiparameter, automated hematology analyzers for in vitro diagnostic use in screening patient populations found in clinical laboratories. The DxH 800 is availa
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0153-2014·2013-11-13

    Beckman Coulter ISE REF Valve Recall for Chemistry Analyzers

    Beckman Coulter is recalling ISE REF Valves for AU480, AU680, and AU5800 analyzers due to premature valve failure that may affect test accuracy.

    Product
    ISE REF Valve, Part No. MU7638 for the AU480, AU680, and AU5800 Chemistry Analyzer. Automated chemistry analyzers that measures analytes in samples.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0152-2014·2013-11-13

    Beckman Coulter Recalls ISE REF Valves for Chemistry Analyzers

    Beckman Coulter is recalling ISE REF Valves for AU series chemistry analyzers because premature valve failure may affect test accuracy.

    Product
    ISE REF Valve, Part No. MU3226 for the AU400, AU640, AU2700, and AU5400 Chemistry Analyzer. Automated chemistry analyzers that measures analytes in samples.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0113-2014·2013-11-06

    Beckman Coulter LH 750 and LH 780 Hematology Analyzers Recalled for Valve Failure

    Beckman Coulter is recalling LH 750 and LH 780 hematology analyzers because check valves may fail, causing air or liquid leaks.

    Product
    COULTER LH 750 and LH 780 Analyzers. The COULTER LH 750 Hematology Analyzer is a quantitative, automated hematology analyzer and leukocyte differential counter For In Vitro Diagnostic Use in clinical laboratories. The COULTER LH 750 Hematology Analyzer provides automated Reti
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1997-2013·2013-08-28

    Beckman Coulter Recalls Hemoccult ICT Fecal Occult Blood Test Kits

    Beckman Coulter is recalling 68,116 Hemoccult ICT units due to increased sensitivity at borderline positive levels, which may cause false positives.

    Product
    Hemoccult ICT (Immunochemical Fecal Occult Blood Test) is a rapid, visually read, qualitative immunochemical chromatographic method for detection of human hemoglobin in fecal samples.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1951-2013·2013-08-21

    Beckman Coulter Recalls ISE Electrolyte Reference Reagent for Calibration Issues

    Beckman Coulter is recalling ISE Electrolyte Reference reagent because it may exceed instrument calibration limits, potentially affecting potassium measurements.

    Product
    ISE Electrolyte Reference reagent (for Synchron LX Systems and UniCel DxC 600/800 Systems), Part No. A28937, A28945, 467935, 467915. Product Usage: ISE Electrolyte Buffer reagent and ISE Electrolyte Reference reagent, when used in conjunction with SYNCHRON LX System(s), UniCe
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1873-2013·2013-08-14

    Beckman Coulter AU5800 Clinical Chemistry Analyzer Recall for Labeling Defect

    Beckman Coulter is recalling AU5800 Clinical Chemistry Analyzers because the diluted detergent tank lacks labeling for the on/off valve disposition.

    Product
    Beckman Coulter AU5800 Clinical Chemistry Analyzer, All Serial Numbers. An automated chemistry analyzer that measures analytes in samples, in combination with appropriate reagents, calibrators, quality control (QC), material and other accessories.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1834-2013·2013-08-07

    Beckman Coulter AU5800 Clinical Chemistry Analyzer Software Recall

    Beckman Coulter is recalling AU5800 Clinical Chemistry Analyzers due to a software error causing concentrated wash solution pump failures and leaks.

    Product
    AU5800 Clinical Chemistry Analyzer with Automation Ready Connection (All Software Versions), Model Numbers AU5811, AU5821, AU5831 and AU5841. This system is for in vitro diagnostic use only.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1613-2013·2013-07-03

    Beckman Coulter Recalls Lactate Reagent Due to Calibration Failures

    Beckman Coulter is recalling 3,353 units of SYNCHRON Lactate Reagent because improper storage caused calibration failures, potentially delaying test results.

    Product
    SYNCHRON System(s) Lactate (LACT) Reagent. Product Usage: Lactate (LACT) reagent, when used in conjunction with Synchron LX¿ System(s), UniCel¿ DxC 600/800 System(s) and Synchron¿ Systems Multi Calibrator, is intended for the quantitative determination of lactate concentratio
    Category
    Medical Device
    Distribution
    Distributed nationwide

About this company

Community-sourced company facts from Wikidata, not from any recall agency. This is background on the corporate entity — it says nothing about the recall(s) listed on this page, which come from the agency source notice above.

Beckman Coulter

company

Country
United States
Founded
1935
Parent company
Danaher Corporation

Official website

Source: Wikidata (Q479952), licensed CC0. Wikidata is community-edited and may not reflect the current corporate structure.