BEUDAMED
    FDA Enforcement Class II Terminated

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

    Recall: Z-1375-2015 · Reported April 8, 2015

    Enforcement

    Recall Number
    Z-1375-2015
    Event ID
    70811
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    BD Biosciences, Systems & Reagents
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 8, 2015
    Initiation Date
    March 23, 2015
    Classification Date
    April 2, 2015
    Termination Date
    February 26, 2016
    Address
    2350 Qume Dr, N/A, San Jose, CA, 95131-1812, United States

    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.

    Code Info

    Lot 5008762, Exp 11/30/16.

    Distribution

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

    Quantity

    9