BEUDAMED
    FDA Enforcement Class III Ongoing

    Apo B Reagent, REF: OSR6143

    Recall: Z-1815-2025 · Reported June 4, 2025

    Enforcement

    Recall Number
    Z-1815-2025
    Event ID
    96746
    Classification
    Class III
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Beckman Coulter Ireland, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    June 4, 2025
    Initiation Date
    April 23, 2025
    Classification Date
    May 23, 2025
    Address
    Lismeehan, N/A, O'Callaghan'S Mills, N/A, N/A, Ireland

    Description

    Apo B Reagent, REF: OSR6143

    Reason

    The product Value Assignment Sheet (VAS) is used in calibration of the device. An erroneous value was included in the VAS which has the potential to generate an incorrect APO B patient result which could exceed the total allowable error for the APO B assay (11.6%). The error results in results with a positive bias up to 42%. However, based on the mitigating factors the risk to health is considered to be negligible or limited.

    Code Info

    Lot # 2631/UDI: 15099590010409

    Distribution

    Worldwide - US Nationwide distribution in the states of AZ, CA, CO, FL, GA, IL, IN, MD, MI, NJ, NY, OH, OK, OR, PA, TX, VA, WA, WV and the countries of Argentina, Australia, Belarus, Belgium, Bulgaria, Canada, China, Czechia, Egypt, Estonia, France, Germany, Ghana, Greece, Hong Kong, India, Ireland, Israel, Italy, Korea, Republic of, Malaysia, Netherlands, New Zealand, Russian Federation, Saudi Arabia, Slovakia, Spain, Switzerland, Taiwan, Province of China, United Kingdom of Great Britain and Northern Ireland, United States of America, Viet Nam.

    Quantity

    2747 units