BEUDAMED
    FDA Recall Terminated

    CD123 (9F5) PE Catalog number 649453 Analyte Specific Reagent

    Recall: Z-1375-2015 · Initiated March 23, 2015

    Recall

    Recall Number
    Z-1375-2015
    Event Number
    70811
    Firm
    BD Biosciences, Systems & Reagents
    FEI Number
    2916837
    Product Code
    MVU
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    March 23, 2015
    Posted
    April 2, 2015
    Terminated
    February 26, 2016
    Address
    2350 Qume Dr, San Jose, CA, 95131-1812

    Description

    CD123 (9F5) PE Catalog number 649453 Analyte Specific Reagent

    Reason

    One lot of BD CD123 PE (ASR) has been determined to contain a low amount of CD4 antibody and may result in an unexpected staining pattern.

    Action

    Recall letters were sent to affected sites on March 23, 2015 by certified mail. All product in house was placed on ship hold and remaining inventory is in process of being scrapped.

    Distribution

    US Distribution in states of: MO, GA, AZ, NE, TX, VA

    Quantity

    9