BEUDAMED
    FDA Enforcement Class II Terminated

    BD Trucount Absolute Counting Tubes: Model number: 340334 IVD; BD Trucount tubes are used for determining absolute counts of leucocytes in blood. BD Trucount tubes are designed for use with in vitro diagnostic products such as BD Tritest reagents, and a suitably equipped flow cytometer. BD Trucount tubes can be used with the BD FACS Loader.

    Recall: Z-1570-2016 · Reported May 4, 2016

    Enforcement

    Recall Number
    Z-1570-2016
    Event ID
    73748
    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
    May 4, 2016
    Initiation Date
    March 31, 2016
    Classification Date
    April 26, 2016
    Termination Date
    May 26, 2017
    Address
    2350 Qume Dr, N/A, San Jose, CA, 95131-1812, United States

    Description

    BD Trucount Absolute Counting Tubes: Model number: 340334 IVD; BD Trucount tubes are used for determining absolute counts of leucocytes in blood. BD Trucount tubes are designed for use with in vitro diagnostic products such as BD Tritest reagents, and a suitably equipped flow cytometer. BD Trucount tubes can be used with the BD FACS Loader.

    Reason

    One lot of lot of BD Trucount tubes may contain tubes from another lot. There is a 3.3% difference in bead counts between the two lots found within some of the pouches and presents a low risk to patient safety or impact to data if this product is used.

    Code Info

    Model: 340334; Manufacaturing lot: 534964

    Distribution

    Worldwide Distribution - US including MD, CA GA. WA. PA. CO. TN. FL. NC. DE. VA, CT, LA. NC, NY, OH, MN, NH and Internationally to China, Japan, and India.

    Quantity

    1743; 467 US and 1276 International