BEUDAMED
    FDA Recall Open, Classified

    Access PCT Reagent Pack, Catalog Number C53987, when used on Access 2 and UniCel Dxl Immunoassay Systems

    Recall: Z-1112-2025 · Initiated January 2, 2025

    Recall

    Recall Number
    Z-1112-2025
    Event Number
    96089
    Firm
    Beckman Coulter Inc.
    FEI Number
    2050012
    Product Code
    PTF
    Status
    Open, Classified
    Root Cause
    Under Investigation by firm
    Initiated
    January 2, 2025
    Posted
    February 5, 2025
    Address
    250 S Kraemer Blvd, Brea, CA, 92821-6232

    Description

    Access PCT Reagent Pack, Catalog Number C53987, when used on Access 2 and UniCel Dxl Immunoassay Systems

    Reason

    Identified reagent lots are experiencing a high rate of calibration failures with failure code of "Max Iterate" on Access 2 and UniCel Dxl Immunoassay Systems. Reporting of results may be delayed due to the time required to achieve a passing calibration curve.

    Action

    An Urgent Medical Device Recall letter was sent during the week of December 30, 2024, to the affected customers via first class mail and email. If a passing calibration curve can be generated using the Access PCT reagent lots listed above, no action is needed. If repeated calibration failures with a failure code of Max Iterate are obtained using the Access PCT reagent lots listed above, discontinue using the affected reagent lot number.

    Distribution

    Worldwide distribution - US Nationwide and the countries of Austria, Bahrain, Bangladesh, Belgium, Bosnia and Herzegovina, Brazil, Canada, Chile, China, Croatia, Czechia, Denmark, France, Germany, Greece, Hungary, India, Ireland, Italy, Kazakhstan, Korea, Republic of, Malaysia, Mexico, Peru, Philippines, Poland, Puerto Rico, Romania, Slovakia, South Africa, Spain, Switzerland, Thailand, Tunisia, Turkey, United Arab Emirates, United Kingdom of Great Britain and Northern Ireland, Viet Nam.

    Quantity

    6,994 US; 10,067 OUS