BEUDAMED
    FDA Enforcement Class II Ongoing

    IMMAGE Immunochemistry Systems IGM Immunoglobulin M Reagent REF 447610 IGM reagent, when used in conjunction with IMMAGE Immunochemistry Systems and Calibrator 1, is intended for the quantitative determination of immunoglobulin M (IGM) in human serum by rate nephelometry.

    Recall: Z-0118-2025 · Reported October 23, 2024

    Enforcement

    Recall Number
    Z-0118-2025
    Event ID
    95285
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Beckman Coulter Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    October 23, 2024
    Initiation Date
    July 31, 2024
    Classification Date
    October 17, 2024
    Address
    250 S Kraemer Blvd, Brea, CA, 92821-6232, United States

    Description

    IMMAGE Immunochemistry Systems IGM Immunoglobulin M Reagent REF 447610 IGM reagent, when used in conjunction with IMMAGE Immunochemistry Systems and Calibrator 1, is intended for the quantitative determination of immunoglobulin M (IGM) in human serum by rate nephelometry.

    Reason

    Firm identified two lots of reagents that are not meeting the sensitivity statement in the IFU

    Code Info

    Catalog Number: 447610 UDI-DI code: 15099590221195 Lot Numbers: M307362 M309410

    Distribution

    U.S.: AZ, CA, CO, FL, GA, HI, IL, MA, MI, MO, ND, NY, OH, PA, and TX O.U.S.: Australia, Belgium, Brazil, Chile, China, Czechia, Ecuador, France, Germany, Greece, Hong Kong, India, Italy, Kuwait, Mexico, Philippines, Poland, Portugal, Saudi Arabia, Slovakia, Spain, Sweden, Taiwan Province of China, and Turkey,

    Quantity

    12,102 reagents