BEUDAMED
    FDA Recall Terminated

    BD Multi Check CD4 Low Control Catalog No. 340916 is intended as a complete process control for immunophenotyping by flow cytometry.

    Recall: Z-2233-2014 · Initiated July 18, 2014

    Recall

    Recall Number
    Z-2233-2014
    Event Number
    68892
    Firm
    BD Biosciences, Systems & Reagents
    FEI Number
    2916837
    Product Code
    GKZ
    Status
    Terminated
    Root Cause
    Labeling mix-ups
    Initiated
    July 18, 2014
    Posted
    August 14, 2014
    Terminated
    May 19, 2015
    Address
    2350 Qume Dr, San Jose, CA, 95131-1812

    Description

    BD Multi Check CD4 Low Control Catalog No. 340916 is intended as a complete process control for immunophenotyping by flow cytometry.

    Reason

    The outer box label contains the incorrect distribution date: Box states 2017-09-02 ; should be 2014-09-02

    Action

    Global hold initiated on July 18, 2014. Customer letters sent by certified mail on July 18, 2014 to advised users of the problem.

    Distribution

    IN, MA, TX, VA, Ca, KY, MD, PA, GA, and BD locations in Singapore and Belgium

    Quantity

    85