BEUDAMED
    FDA Enforcement Class II Terminated

    BD Trucount Tubes: Catalog number: 340334 Hematology: BD Trucount tubes are used for determining absolute counts of leucocytes in blood.

    Recall: Z-2252-2016 · Reported July 27, 2016

    Enforcement

    Recall Number
    Z-2252-2016
    Event ID
    74537
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Becton, Dickinson and Company, BD Biosciences
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 27, 2016
    Initiation Date
    June 24, 2016
    Classification Date
    July 21, 2016
    Termination Date
    December 2, 2016
    Address
    2350 Qume Dr, N/A, San Jose, CA, 95131-1812, United States

    Description

    BD Trucount Tubes: Catalog number: 340334 Hematology: BD Trucount tubes are used for determining absolute counts of leucocytes in blood.

    Reason

    One lot of BD Trucount Absolute Counting Tubes (IVD) may not be sealed properly and exposure to ambient environment can rapidly degrade the performance of the product.

    Code Info

    Catalog 340334, Lot ;6083708 (embossing ID of (160216T3)

    Distribution

    USA Distribution to the states of : NC, WA, WI, NJ, PR, MD, NY, MA, CA, NY , MD, KY, IN, VA, SD, PA, OH, AR, AZ and Foreign to : Canada, Belgium and Chile

    Quantity

    328 US, 516 International