BEUDAMED
    FDA Recall Open, Classified

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

    Recall: Z-1572-2023 · Initiated February 28, 2023

    Recall

    Recall Number
    Z-1572-2023
    Event Number
    91889
    Firm
    Bio-Rad Laboratories, Inc.
    FEI Number
    3022521
    Product Code
    MID
    Status
    Open, Classified
    Root Cause
    Under Investigation by firm
    Initiated
    February 28, 2023
    Posted
    May 10, 2023
    Address
    6565 185th Ave Ne, Redmond, WA, 98052-5039

    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.

    Action

    On February 28, 2023, Bio-Rad Laboratories issued an "Urgent: Medical Device Recall" letter to affected consignees. In addition, to informing consignees about the recall, they ask consignees to take the following actions: We are requesting that customers perform quality control using the BioPlex APLS IgM Control Set (Catalog No. 663-2030, UDI GTIN 00847865000642) with each reagent pack ( single pack validation ) of BioPlex 2200 APLS IgM Reagent Pack, Lot No. 301538, until replacement product is provided. If QC fails (controls below or above the acceptable range), please discontinue use of the reagent pack and dispose of it according to local waste management procedures. If the control values are within the acceptable range, the reagent pack may be used and patient results may be released. If you have distributed or transferred this product to any other Bio-Rad customers, or to any other laboratories from your site, please notify those customers of this field action. Please complete the attached Customer Response Form and return it to your local Bio-Rad Technical Support so they can assist you with obtaining replacement reagent packs as needed.

    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