BEUDAMED
    FDA Enforcement Class II Ongoing

    CMV IgM EIA, in vitro diagnostic.

    Recall: Z-0342-2023 · Reported December 7, 2022

    Enforcement

    Recall Number
    Z-0342-2023
    Event ID
    91106
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Bio-Rad Laboratories, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    December 7, 2022
    Initiation Date
    October 19, 2022
    Classification Date
    November 30, 2022
    Address
    6565 185th Ave Ne, Redmond, WA, 98052-5039, United States

    Description

    CMV IgM EIA, in vitro diagnostic.

    Reason

    Due to an unusual increase in the positivity rate with human IgM antibodies to cytomegalovirus (CMV) Enzyme Immunoassay (EIA).

    Code Info

    Catalog Number: 25178 UDI-DI Code: 00847865010733 Lot Numbers: B02022 E10022 G05022

    Distribution

    U.S.: CA, CO, FL, GA, HI, IA, MA, MN, NC, NH, NJ, PA, TN, and TX O.U.S.: None

    Quantity

    180 kits