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.

301–325 of 334

  • HighFDA (Devices)·Z-1430-2013·2013-06-05

    Beckman Coulter Recalls AU2700 and AU5400 Clinical Chemistry Analyzers

    Beckman Coulter is recalling AU2700 and AU5400 Clinical Chemistry Analyzers because tubing connections may leak concentrated detergent.

    Product
    AU2700 Clinical Chemistry Analyzer AU5400 Clinical Chemistry Analyzer Perform automated analysis of serum, urine, and other body fluids, including whole blood.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1400-2013·2013-06-05

    Beckman Coulter Recalls Lactate Reagent Due to Error Messages

    Beckman Coulter is recalling Lactate Reagent Lot M206209 because it may fail to report numerical values for high lactate concentrations.

    Product
    Synchron LX System(s) and UniCel DxC 600/800 System(s) Lactate Reagent, Part Number: A95550 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 quan
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1167-2013·2013-05-01

    Beckman Coulter AU5800 Clinical Chemistry Analyzer Recalled for Software Error

    Beckman Coulter is recalling 490 AU5800 Clinical Chemistry Analyzers due to a software error that may cause the system to misidentify samples and report erroneous patient results.

    Product
    AU5800 Clinical Chemistry Analyzer The Beckman Coulter AU5800 Clinical Chemistry Analyzer is an automated chemistry analyzer that measures analytes in samples, in combination with appropriate reagents, calibrators, quality control (QC) material and other accessories. This syst
    Category
    Medical Device
    Distribution
    18 states
  • HighFDA (Devices)·Z-1034-2013·2013-04-10

    Beckman Coulter Synchron LXi 725 Clinical System Recalled for Defective Pulley

    Beckman Coulter is recalling 83 Synchron LXi 725 Clinical Systems because a defective incubator belt pulley may create debris that falls into reaction vessels, potentially causing erroneous test results.

    Product
    Synchron LXi 725 Clinical System; P/N 107405S Product Usage: The Access Immunoassay Systems are in vitro diagnostic devices 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-1035-2013·2013-04-10

    Beckman Coulter Recalls UniCel DxC 600i Synchron Access Clinical Systems

    Beckman Coulter is recalling 956 UniCel DxC 600i Synchron Access Clinical Systems because a defective incubator belt pulley may create debris that falls into reaction vessels, potentially causing erroneous test results.

    Product
    UniCel DxC 600i Synchron Access Clinical System; P/N 107405S Product Usage: The Access Immunoassay Systems are in vitro diagnostic devices 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-1033-2013·2013-04-10

    Beckman Coulter Access 2 Immunoassay System Recall for Defective Pulley

    Beckman Coulter is recalling Access 2 Immunoassay Systems because a defective aluminum incubator belt pulley may create debris that falls into reaction vessels, risking erroneous test results.

    Product
    Access 2 Immunoassay System; P/N 107405S 2/12 The Access Immunoassay Systems are in vitro diagnostic devices used for the quantitative, semi-quantitative or qualitative determination of various analyte concentrations found in human body fluids.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1032-2013·2013-04-10

    Beckman Coulter Access Immunoassay System Recalled for Defective Belt Pulley

    Beckman Coulter is recalling Access Immunoassay Systems because a defective belt pulley creates debris that may cause erroneous test results.

    Product
    Access Immunoassay System; P/N 107405S Product Usage: The Access Immunoassay Systems are in vitro diagnostic devices used for the quantitative, semi-quantitative or qualitative determination of various analyte concentrations found in human body fluids.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0958-2013·2013-03-27

    Beckman Coulter Recalls Creatinine Reagents for Calibration Instructions

    Beckman Coulter is recalling Creatinine reagents to provide updated instructions for calibration stability and quality control frequency.

    Product
    Creatinine, Part Numbers OSR6178, OSR6678 Product Usage: System reagent for the quantitative determination of Creatinine in human serum and urine on Beckman Coulter AU analyzers.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0913-2013·2013-03-13

    Beckman Coulter AU5800 Clinical Chemistry Analyzer Software Recall

    Beckman Coulter is recalling AU5800 Clinical Chemistry Analyzers due to a software data storage limitation that may prevent saving of certain sample results.

    Product
    Beckman Coulter AU5800 Clinical Chemistry Analyzer. An automated chemistry analyzer that measures analytes such as Glucose, Magnesium, and Potassium.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0612-2013·2013-01-02

    Beckman Coulter Recalls Access Immunoassay Systems Due to Pulley Defects

    Beckman Coulter is recalling Access Immunoassay Systems because pulley drive components may break or disconnect, causing inadequate washing or mixing.

    Product
    Access Immunoassay System, Access 2 Immunoassay System, Synchron LXi 725 Clinical System, UniCel DxC 600i Synchron Access Clinical System Part Numbers: Access  81600; Access 2  81600N, 386220, A69186, A25656, A12900; Access 2 (LXi)  A15642; Access 2 Section, DxC 600i
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0613-2013·2013-01-02

    Beckman Coulter Recalls Access Total T4 Calibrators Due to Expiration Date Error

    Beckman Coulter is recalling Access Total T4 Calibrators because specific lots do not meet their claimed 12-month expiration date.

    Product
    Access Immunoassay Systems Total T4 Calibrators, Part Number: 33805. The Access Total T4 Calibrators are intended to calibrate the Access Total T4 assay for the quantitative determination of total thyroxine (T4) levels in human serum and plasma using the Access Immunoassay S
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0572-2013·2012-12-26

    Beckman Coulter Recalls Access hLH Calibrators Due to Stability Test Failures

    Beckman Coulter is recalling Access hLH Calibrators because stability testing failed to verify expiration dating. The affected lots did not meet procedural requirements for shelf-life.

    Product
    The Access hLH assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of luteinizing hormone (LH) levels in human serum and plasma using the Access Immunoassay Systems. The Access hLH Calibrators are intended to calibrate the Access h
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0346-2013·2012-11-28

    Beckman Coulter Recalls UniCel Dxl 600 Access Immunoassay Systems

    Beckman Coulter is recalling 432 UniCel Dxl 600 Access Immunoassay Systems due to confirmed field modifications to probe assemblies.

    Product
    UniCel Dxl 600 Access Immunoassay System, Part Numbers: A30260, A71460, and A71461. The UniCel DxI Immunoassay System is an in vitro diagnostic device used for the quantitative, semi-quantitative or qualitative determination of various analyte concentrations found in human bod
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0347-2013·2012-11-28

    Beckman Coulter Recalls UniCel DxC Immunoassay Systems Due to Field Modifications

    Beckman Coulter is recalling UniCel DxC and Dxl Immunoassay Systems because field modifications were made to the aspirate and dispense probe assemblies.

    Product
    UniCel DxC 880i, 860i, 680i, and 660i Integrated Systems, Part Numbers: A64871, A64903, A64935, A59102. The UniCel DxI Immunoassay System is an in vitro diagnostic device used for the quantitative, semi-quantitative or qualitative determination of various analyte concentration
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0345-2013·2012-11-28

    Beckman Coulter Recalls UniCel Dxl 800 Access Immunoassay Systems

    Beckman Coulter is recalling 1,756 UniCel Dxl 800 Access Immunoassay Systems due to confirmed field modifications to probe assemblies.

    Product
    UniCel Dxl 800 Access Immunoassay System, Part Numbers: 973100, A71456, and A71457. The UniCel DxI Immunoassay System is an in vitro diagnostic device used for the quantitative, semi-quantitative or qualitative determination of various analyte concentrations found in human bod
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0123-2013·2012-10-31

    Beckman Coulter Recalls DxC 600/800 Analyzers Due to Software Alignment Issue

    Beckman Coulter is recalling 7 UniCel DxC 600/800 analyzers because software v5.0.11 prevents operators from performing a necessary alignment procedure.

    Product
    UniCel¿ DxC 600/800 with Software v5.0.11, Part Number B12218. The UniCel¿ DxC Synchron¿ Clinical Systems are fully automated, computercontrolled clinical chemistry analyzers designed for the in vitro determination of a variety of general chemistries, therapeutic drugs, and o
    Category
    Medical Device
    Distribution
    2 states
  • LowFDA (Devices)·Z-0110-2013·2012-10-31

    Beckman Coulter Recalls Synchron Multi Calibrator Diskettes Due to Mislabeling

    Beckman Coulter is recalling Synchron Multi Calibrator Diskettes because some units may be mislabeled as Thyroxine (T4) Reagent Calibrator Diskettes.

    Product
    Synchron Systems Synchron Calibrator Multi Calibrator Diskettes, Part Number 442600. The SYNCHRON MULTI-CALIBRATOR, used in conjunction with SYNCHRON reagents, is intended for use on SYNCHRON Systems for the calibration of Albumin, Blood Urea Nitrogen (Urea), Calcium, Choleste
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0056-2013·2012-10-24

    Beckman Coulter AutoMate 1250 and 2550 Sample Processing System Recall

    Beckman Coulter is recalling AutoMate 1250 and 2550 systems due to a risk of sample misidentification caused by duplicate barcode labels.

    Product
    AutoMate 1250 and AutoMate 2550, Part Numbers ODL25125 and ODL25255. The AutoMate 1200/2500 System Series is a semi-open, pre- and post-analytical sample processing and sorting system. The base system automates the sample sorting, decapping, and archiving processes. Handling a
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0059-2013·2012-10-24

    Beckman Coulter Recalls Unicel Closed Tube Aliquotter Units Due to Hardware Error

    Beckman Coulter is recalling 18 Unicel Closed Tube Aliquotter units because a hardware motion error may occur. The recall covers units distributed in the US and several international locations.

    Product
    Unicel Closed Tube Aliquotter (UCTA) for UniCel DxC 660i, UniCel DxC 680i, UniCel DxC 860i, UniCel DxC 880i Synchron Access Clinical Systems. Part Number A45853. Product Usage: The UniCel DxC Synchron Clinical Systems are fully automated, computer-controlled clinical chemist
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0047-2013·2012-10-17

    Beckman Coulter Recalls Access Folate Calibrators Due to Falsely Elevated Results

    Beckman Coulter is recalling Access Folate Calibrators because they may produce falsely elevated results that could mask a folate deficiency.

    Product
    Access Folate WHO Calibrators, Part Number: A98033. The Access Folate Calibrators are intended to calibrate the Access Folate assay using the Access Immunoassay Systems
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0046-2013·2012-10-17

    Beckman Coulter Recalls Access Folate Calibrators Due to Falsely Elevated Results

    Beckman Coulter is recalling Access Folate Calibrators because they may produce falsely elevated results that could mask a folate deficiency.

    Product
    Access Folate Calibrators, Part Number: A14207. The Access Folate assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of folic acid levels in human serum, plasma (heparin) or red blood cells using the Access Immunoassay Systems. Th
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0021-2013·2012-10-17

    Beckman Coulter Recalls UniCel DxH 800 Hematology Analyzers

    Beckman Coulter is recalling UniCel DxH 800 hematology analyzers because drain ports may plug, causing biohazard exposure or incorrect test results.

    Product
    Unicel DxH 800 Coulter Cellular Analysis System, Part Number 629029. The UniCel DxH 800 Analyzer is a quantitative, automated hematology analyzer for in vitro diagnostic use in screening patient populations found in clinical laboratories. The UniCel DxH 800 Analyzer provides a
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0035-2013·2012-10-17

    Beckman Coulter Recalls TetraCXP Software for Labeling Updates

    Beckman Coulter is recalling TetraCXP software and CYTO-STAT reagents to update specimen stability claims in the product labeling.

    Product
    TetraCXP Software System, Part Number A40051. Allows simultaneous identification and enumeration of total CD3+, total CD4+, total CD8+, dual CD3+/CD4+, dual CD3+/CD8+ and/or total CD3+, CD19+ and CD3+/CD56+ lymphocyte percentages and absolute counts in whole blood by flow cyto
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0034-2013·2012-10-17

    Beckman Coulter Recalls CYTO-STAT Reagents Due to Labeling Stability Claims

    Beckman Coulter is recalling CYTO-STAT tetraCHROME reagents because stability claims in the product labeling need to be updated to align with current standards.

    Product
    CYTO-STAT tetraCHROME CD45- FITC/CD56-RD1/CD19-ECD/CD3-PC5, Part Number 6607073. Allows simultaneous identification and enumeration of total CD3+, total CD4+, total CD8+, dual CD3+/CD4+, dual CD3+/CD8+ and/or total CD3+, CD19+ and CD3+/CD56+ lymphocyte percentages and absolute c
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0033-2013·2012-10-17

    Beckman Coulter Recalls CYTO-STAT Reagents Due to Labeling Updates

    Beckman Coulter is recalling CYTO-STAT tetraCHROME reagents because stability claims in the product labeling need to be updated to align with current standards.

    Product
    CYTO-STAT tetraCHROME CD45-FITC/CD4-RD1/CD8-ECD/CD3-PC5, Part Number 6607013. Allows simultaneous identification and enumeration of total CD3+, total CD4+, total CD8+, dual CD3+/CD4+, dual CD3+/CD8+ and/or total CD3+, CD19+ and CD3+/CD56+ lymphocyte percentages and absolute co
    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.