BEUDAMED
    FDA Recall Open, Classified

    BioPlex 2200 REF 12000670 ToRC IgM Reagent Pack

    Recall: Z-1096-2022 · Initiated April 14, 2022

    Recall

    Recall Number
    Z-1096-2022
    Event Number
    90026
    Firm
    Bio-Rad Laboratories, Inc.
    FEI Number
    3022521
    Product Code
    LIP
    Status
    Open, Classified
    Root Cause
    Under Investigation by firm
    Initiated
    April 14, 2022
    Address
    6565 185th Ave Ne, Redmond, WA, 98052-5039

    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.

    Action

    On 04/14/2022, Bio-Rad Laboratories sent an "URGENT: Medical Device Recall" letter via FedEx to customers informing them that Bio-Rad has identified a performance concern for the CMV IgM analyte in the BioPlex 2200 ToRC IgM kit lot 301388. The CMV IgM analyte has demonstrated variable elevated background depending on the handling of the reagent pack. Agitation of the conjugate within the reagent pack has demonstrated a potential for both false negative and false positive results for the CMV IgM assay. QC failures may prevent the release of incorrect results; however, QC may not detect all occurrences of the issue. Customers are instructed to immediately discontinue use and to dispose of any unused product of Lot No. 301388. If the affected lot has been further distributed or transferred the product to other Bio-Rad customers, or labs, these customer/labs should be notified of this field action/recall. For questions or further assistance, contact local Bio-Rad Technical Support.

    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