BEUDAMED
    FDA Recall Open, Classified

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

    Recall: Z-1233-2025 · Initiated January 10, 2025

    Recall

    Recall Number
    Z-1233-2025
    Event Number
    96193
    Firm
    BECKMAN COULTER LABORATORY SYSTEMS (SUZHOU) CO., LTD. No.
    FEI Number
    3027977508
    Product Code
    JJE
    Status
    Open, Classified
    Root Cause
    Software change control
    Initiated
    January 10, 2025
    Posted
    February 25, 2025
    Address
    11 Shengpu Street Zhensheng Road, Pingjiang Suzhou 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.

    Action

    On 1/10/2025, recall notices were mailed to customers who were asked to do the following: 1) Replace and discard any reagent bottles that were on-board the analyzer at the time of any software upgrade. 2) Review Quality Control data and actions taken, for shifts out of allowed laboratory range which could have indicated potential deterioration in reagent stability. 3) Firm recommends sharing the content of this letter with your laboratory and/or Medical Director to determine if a review of previous patient test results should be conducted. 4) If specific software upgrade date is required, contact firm. 5) Please share this information with your laboratory staff and retain this notification as part of your laboratory Quality System documentation. If you have forwarded any of the affected product(s) listed above to another laboratory, please provide them a copy of this letter. This issue will not occur with future software updates. If you have any questions regarding this notice, please contact the firm's Customer Support Center: Website: http://www.beckmancoulter.com Hotline: (800) 854-3633

    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