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.

326–334 of 334

  • ModerateFDA (Devices)·Z-0016-2013·2012-10-17

    Beckman Coulter Recalls Active Renin IRMA Kit Due to Stability Issues

    Beckman Coulter is recalling the Active Renin IRMA Kit because decreased stability in coated tubes may cause falsely elevated test results.

    Product
    Active Renin IRMA Kit, Part Number DSL25100 Product Usage: The Renin IRMA; DSL25100 immunoradiometric assay kit provides materials for the quantitative measurement of Renin in plasma. This assay is intended for in vitro diagnostic use.
    Category
    Medical Device
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-0002-2013·2012-10-10

    Beckman Coulter PrepPlus Recalled for Reagent Level Sense Failures

    Beckman Coulter is recalling the PrepPlus pipetting system because it may fail to warn users when reagent levels are low or out.

    Product
    COULTER PrepPlus, Part Number: 286600 Product Usage: The COULTER PrepPlus, is a microprocessor-controlled pipetting and diluting system, designed for automating sample preparation or assay methods. It is capable of aspirating and dispensing liquid samples.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0003-2013·2012-10-10

    Beckman Coulter Recalls IMMAGE Rheumatoid Factor Reagent Due to False Results

    Beckman Coulter is recalling specific lots of IMMAGE Rheumatoid Factor reagent because they may produce false abnormal results in patient samples.

    Product
    IMMAGE Immunochemistry Systems Rheumatoid Factor (RF) Reagent, PN 447070 The IMMAGE Immunochemistry Systems Rheumatoid Factor (RF) reagent, in conjunction with Beckman Cal 5 Plus, is intended for use in the quantitative determination of human rheumatoid factor concentrations i
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2259-2012·2012-08-29

    Beckman Coulter Recalls UniCel DxC Immunoassay Systems Due to Software Anomaly

    Beckman Coulter is recalling UniCel DxC 660i, 680i, 860i, and 880i systems because a software anomaly may cause erroneous test results.

    Product
    UniCel DxC 660i, 680i, 860i, 880i SYNCHRON Access Clinical Systems, Part Numbers: DxC 660i: A64871; DxC 680i: A64903; DxC 860i: A64935; DxC 880i: A59102. The DxI Immunoassay System is an in vitro diagnostic device used for the quantitative, semi-quantitative or qualita
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2226-2012·2012-08-29

    Beckman Coulter DxH Slidemaker Stainer Floor Stand Recall for Sharp Edges

    Beckman Coulter is recalling 41 DxH Slidemaker Stainer Floor Stands because missing vinyl caps expose sharp edges on drawer slides, posing a physical injury risk to operators.

    Product
    UniCel DxH Slidemaker Stainer Stainer Floor Cabinet, PN A96152. The DxH Slidemaker Stainer is a fully automated slide preparation and staining device that aspirates a whole blood-sample, smears a blood film on a clean microscope slide, and delivers a variety of fixatives, stai
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2257-2012·2012-08-29

    Beckman Coulter Recalls UniCel DxI 800 Immunoassay Systems Due to Software Anomaly

    Beckman Coulter is recalling UniCel DxI 800 Access Immunoassay Systems because a software anomaly may cause erroneous test results.

    Product
    UniCel DxI 800 Access Immunoassay Systems, Part Numbers: Dxl 800: 937100; Dxl 800 Remanufactured: A25288; Dxl 800 with spot B: A71456; Dxl 800 Reconditioned: A25285. The DxI Immunoassay System is an in vitro diagnostic device used for the quantitative, semi-quantitative or
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2258-2012·2012-08-29

    Beckman Coulter Recalls UniCel DxI 600 Immunoassay Systems Due to Software Anomaly

    Beckman Coulter is recalling UniCel DxI 600 Access Immunoassay Systems because a software anomaly may cause erroneous test results.

    Product
    UniCel DxI 600 Access Immunoassay Systems, Part Numbers: Dxl 600: A30260; Dxl 600 with spot B: A71460. The DxI Immunoassay System is an in vitro diagnostic device used for the quantitative, semi-quantitative or qualitative determination of various analyte concentrations fo
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2225-2012·2012-08-29

    Beckman Coulter DxH Slidemaker Stainer Floor Stand Recall for Sharp Edges

    Beckman Coulter is recalling 41 DxH Slidemaker Stainer Floor Stands because missing vinyl caps expose sharp edges on drawer slides, posing a physical injury risk to operators.

    Product
    UniCel DxH Slidemaker Stainer Instrument System, PN 775222. The DxH Slidemaker Stainer is a fully automated slide preparation and staining device that aspirates a whole blood-sample, smears a blood film on a clean microscope slide, and delivers a variety of fixatives, stains,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2227-2012·2012-08-29

    Beckman Coulter Access Total T3 Reagent Recalled for Negative Bias

    Beckman Coulter is recalling Access Total T3 Reagent because test results may show a negative bias when specific sample diluents are used.

    Product
    Access Total T3 Reagent, PN: 33830 The Access Total T3 assay is used for the quantitative determination of triiodothyronine (T3) levels in human serum and plasma in the assessment of thyroid function and diagnosis of thyroid disorders when T3 levels are between 0.1 and 8.0 ng/
    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.