BEUDAMED
    FDA Recall Terminated

    BD CD64 APC-R700; Analyte Specific Reagent; Model 657701; Lot No. 4344945, 5037611 and 5063945. Hematology - used as analyte specific reagent - contamination leads to possibility of unexpected staining pattern.

    Recall: Z-0334-2016 · Initiated October 30, 2015

    Recall

    Recall Number
    Z-0334-2016
    Event Number
    72548
    Firm
    Becton, Dickinson and Company, BD Biosciences
    FEI Number
    2916837
    Product Code
    MVU
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    October 30, 2015
    Terminated
    May 27, 2016
    Address
    2350 Qume Dr, San Jose, CA, 95131-1812

    Description

    BD CD64 APC-R700; Analyte Specific Reagent; Model 657701; Lot No. 4344945, 5037611 and 5063945. Hematology - used as analyte specific reagent - contamination leads to possibility of unexpected staining pattern.

    Reason

    Three lots of CD64 (MD22) are contaminated with CD4 antibody.

    Action

    Urgent Product Recall letters were sent out on October 30, 2015 via certified mail to notify customers of the issue.

    Distribution

    Distributed in the states of FL, WA, PA, IL, GA, RI, TX, ND, and IA.

    Quantity

    23 vials