BEUDAMED
    FDA Enforcement Class II Ongoing

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

    Recall: Z-1112-2025 · Reported February 12, 2025

    Enforcement

    Recall Number
    Z-1112-2025
    Event ID
    96089
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Beckman Coulter Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    February 12, 2025
    Initiation Date
    January 2, 2025
    Classification Date
    February 5, 2025
    Address
    250 S Kraemer Blvd, Brea, CA, 92821-6232, United States

    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.

    Code Info

    UDI-DI 15099590736002 Lots 339062, 439811

    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