BEUDAMED
    FDA Enforcement Class III 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 · Reported August 20, 2014

    Enforcement

    Recall Number
    Z-2233-2014
    Event ID
    68892
    Classification
    Class III
    Status
    Terminated
    Product Type
    Devices
    Firm
    BD Biosciences, Systems & Reagents
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    August 20, 2014
    Initiation Date
    July 18, 2014
    Classification Date
    August 14, 2014
    Termination Date
    May 19, 2015
    Address
    2350 Qume Dr, N/A, San Jose, CA, 95131-1812, United States

    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

    Code Info

    Catalog number 340916; Lot number BM084L

    Distribution

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

    Quantity

    85