BEUDAMED
    FDA Enforcement Class II Ongoing

    DxC 500 AU Clinical Chemistry Analyzer, REF: C63519, and C63520 with affected software.

    Recall: Z-1233-2025 · Reported March 5, 2025

    Enforcement

    Recall Number
    Z-1233-2025
    Event ID
    96193
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    BECKMAN COULTER LABORATORY SYSTEMS (SUZHOU) CO., LTD.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 5, 2025
    Initiation Date
    January 10, 2025
    Classification Date
    February 25, 2025
    Address
    No. 11 Shengpu Street Zhensheng Road, Pingjiang, Suzhou, N/A, N/A, China

    Description

    DxC 500 AU Clinical Chemistry Analyzer, REF: C63519, and C63520 with affected software.

    Reason

    Beckman Coulter has identified an issue which prevents the DxC 500 AU instrument from providing the correct onboard stability (Open Expiration) dates for assays that were loaded prior to a software upgrade (e.g. 1.3 to 1.4, 1.4 to 1.4.1, etc.). As a result, assays that have expired may still be used for sample processing, leading to inaccurate or erroneous patient test results. The issue only happens on assays loaded before instruments doing upgrades and does not impact new installation. It does not impact the assays loaded after upgrade.

    Code Info

    Software Versions: V1.4, V1.4.1, V1.4.2, V1.4.3 REF/UDI-DI/Serial Numbers: C63519/14987666545058/2024090170; C63520/14987666545065/2024070116, 2023070009, 2024010038, 2024010035, 2024050072, 2024040056, 2024030049, 2024020046, 2024070111, 2024030051, 2024030052, 2024010033, 2023090015, 2024060103, 2024060104, 2024060101, 2024080145, 2024020045, 2024020042, 2024020043, 2024020047, 2024060096, 2024040059, 2023100019, 2024030053, 2023070010, 2024070129, 2024070130, 2024020041, 2024090183, 2024010036, 2024010037, 2024070132, 2024070131, 2023100020, 2024050064, 2024050070, 2023090016, 2023110022, 2024070110, 2024060075, 2024060106, 2023110023, 2024010024, 2024010025, 2024050066, 2024010029, 2024060107, 2023080012, 2024040060, 2024050074, 2024040062, 2024010031, 2024030055, 2024080144

    Distribution

    US: MA, CA, SC, LA, OK, GA, AL, TX, OR, ID, CO, MN, NY, MS, PA, WA, IL, MI, PR. OUS: Lebanon, Poland, Ghana, Spain, South Africa, Slovakia, Ghana, Croatia, Seychelles, Australia, Republic of Korea

    Quantity

    56