BEUDAMED
    FDA Enforcement Class II Ongoing

    BioPlex 2200 REF 665-2050, APLS IgM Pack, APLS IgM Reagent Pack

    Recall: Z-1572-2023 · Reported May 17, 2023

    Enforcement

    Recall Number
    Z-1572-2023
    Event ID
    91889
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Bio-Rad Laboratories, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    May 17, 2023
    Initiation Date
    February 28, 2023
    Classification Date
    May 10, 2023
    Address
    6565 185th Ave Ne, N/A, Redmond, WA, 98052-5039, United States

    Description

    BioPlex 2200 REF 665-2050, APLS IgM Pack, APLS IgM Reagent Pack

    Reason

    APLS IgM reagent kits were packaged with the incorrect conjugate, which could lead to an increase in false-positive and false-negative results.

    Code Info

    Lot Code: 301538; UDI-DI: (00)847865000666

    Distribution

    US Nationwide distribution including in the states of AL, AR, AZ, CA, CT, FL, HI, IL, IN, KS, KY, LA, MI, MO, NC, ND, NE, NJ, NM, NY, OH, OK, PR,SC, TN, TX, UT, VT.

    Quantity

    932 Reagent Packs