BEUDAMED
    FDA Recall Open, Classified

    CMV IgM EIA, in vitro diagnostic.

    Recall: Z-0342-2023 · Initiated October 19, 2022

    Recall

    Recall Number
    Z-0342-2023
    Event Number
    91106
    Firm
    Bio-Rad Laboratories, Inc.
    FEI Number
    3022521
    Product Code
    LFZ
    Status
    Open, Classified
    Root Cause
    Nonconforming Material/Component
    Initiated
    October 19, 2022
    Posted
    December 6, 2022
    Address
    6565 185th Ave Ne, Redmond, WA, 98052-5039

    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).

    Action

    On or about 10/19/2022, the firm sent an "URGENT: Medical Device Recall" letter via UPS overnight to customers to inform them, Bio-Rad has received complaints of an unusual increase in the positivity rate with the Bio-Rad CMV IgM EIA kits. Customers are instructed to discontinue use and to dispose of any unused product of Batch NumbersB02022, E10022, and G05022 of the Bio-Rad CMV IgM EIA (Material No. 25178; GTIN/UDI 00847865010733) according to local waste management procedures. If you have further distributed or transferred the product to other Bio-Rad customers, or labs from your site, please be sure to notify those customers of this field action. For any questions regarding this information, please contact Bio-Rad Laboratories Technical Support at 1-800-2BIORAD (1-800-224-6723), option #2, and then option #3, or by emailing [email protected] for further assistance.

    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