The Recall Desk

Manufacturer

Beckman Coulter Biomedical GmbH

7 recalls in our database name Beckman Coulter Biomedical GmbH as the manufacturing or recalling firm.

What the numbers show

Total
7
Critical
0
Severe
0
Most recent
2026-08-12

Of the 7 recalls from Beckman Coulter Biomedical GmbH we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 0 (0%) 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.

1–7 of 7

  • HighFDA (Devices)·Z-2834-2026·2026-08-12

    REMISOL Advance Software Version 2.5 Recalled for Incorrect Test Result Reporting

    Beckman Coulter Biomedical GmbH is recalling REMISOL Advance Software Version 2.5 because it may incorrectly report combo assay test outcomes.

    Product
    REMISOL Advance with Software Version 2.5 UDI-DI code: 15099590802073 The Normand Info REMISOL Advance Data Manager collects and manages data and workflow for 128 connections
    Category
    Medical Device
    Distribution
    5 states
  • HighFDA (Devices)·Z-2980-2024·2024-09-11

    Beckman Power Express Centrifuge Sample Holder May Detach During Operation

    An adhesive joint failure in the PE Centrifuge Temperature Controlled component can cause the metal part to detach inside the centrifuge, risking sample destruction and potential exposure of laboratory technicians to biohazardous material.

    Product
    PE Centrifuge Temperature Controlled, REF: B36366, a component of the Power Express.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2978-2024·2024-09-11

    Medical Device Sample Holder Recalled for Adhesive Joint Failure

    Beckman Coulter Power Express sample holders can fail at the adhesive joint between plastic socket and metal component. This may cause the metal part to detach inside the centrifuge, potentially damaging equipment and exposing lab staff to biohazardous material.

    Product
    Power Express, REF B90918
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2979-2024·2024-09-11

    Power Express PE Centrifuge adhesive joint failure may cause component detachment

    The adhesive joint in this medical device component can fail, causing the metal part to detach. This may damage the centrifuge, destroy patient samples, and potentially expose lab staff to biohazardous material.

    Product
    PE Centrifuge, REF: B36365, a component of the Power Express
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2145-2023·2023-07-26

    Beckman Coulter DxA Automation System software defect may cause incorrect test results

    Beckman Coulter DxA Automation Systems contain a software defect that may cause tests to run on incompatible sample tube types, potentially producing erroneous patient results.

    Product
    Beckman Coulter DxA Automation System, DxA 5000 Fit, REF: B87352, IVD, 200240V, 16A, 50/60HZ, RxOnly
    Category
    Medical Device
    Distribution
    19 states
  • HighFDA (Devices)·Z-2144-2023·2023-07-26

    Beckman Coulter DxA Automation System software defect may produce erroneous patient test results

    A software defect in the Beckman Coulter DxA Automation System may cause tests to be performed on incompatible tube types, potentially producing inaccurate patient results. Affected systems were distributed in the US and internationally.

    Product
    Beckman Coulter DxA Automation System, DxA 5000, REF: B87352, IVD, 200240V, 16A, 50/60HZ, RxOnly
    Category
    Medical Device
    Distribution
    19 states
  • ModerateFDA (Devices)·Z-2983-2020·2020-09-30

    Beckman Coulter Recalls DxA 5000 Automated Sample Handling Systems

    Beckman Coulter is recalling 32 DxA 5000 automated sample handling systems because the instructions for use may be confusing regarding the re-use of sample IDs, leading to undetected barcode re-use.

    Product
    DxA 5000; Catalog Number:B50516; UDI:15099590707118 - Product Usage: The DxA 5000 is a high-speed, modular, automated sample handling system that performs pre-analytical and post-analytical sample processing and storage. The automation system also sorts, routes, and presents samp
    Category
    Medical Device
    Distribution
    Distributed nationwide