BEUDAMED
    FDA Enforcement Class II Ongoing

    BioPlex 2200 REF 12000670 ToRC IgM Reagent Pack

    Recall: Z-1096-2022 · Reported May 25, 2022

    Enforcement

    Recall Number
    Z-1096-2022
    Event ID
    90026
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Bio-Rad Laboratories, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    May 25, 2022
    Initiation Date
    April 14, 2022
    Classification Date
    May 16, 2022
    Address
    6565 185th Ave Ne, N/A, Redmond, WA, 98052-5039, United States

    Description

    BioPlex 2200 REF 12000670 ToRC IgM Reagent Pack

    Reason

    Performance concerns for the CMV IgM analyte. Analyte has demonstrated variable elevated background depending on the handling of the reagent pack.

    Code Info

    Model/Catalog Number: 12000670 UDI-DI (GTIN) Code: 03610520992715 Lot Number: 301388

    Distribution

    Worldwide distribution - U.S. Nationwide distribution in the states of AR, AZ, CA, FL, HI, IA, IL, MI, MN, NE, NY, TN, TX, and WA. The countries of Czech Republic, France, Germany, and Italy.

    Quantity

    348 units