BEUDAMED
    FDA Recall Terminated

    BC Thrombin Reagent . Thrombin Time Test

    Recall: Z-0007-05 · Initiated July 21, 2004

    Recall

    Recall Number
    Z-0007-05
    Event Number
    29987
    Firm
    Dade Behring Inc. Rte 896, Glasgow Business Community
    FEI Number
    2517506
    Product Code
    GJA
    Status
    Terminated
    Root Cause
    Other
    Initiated
    July 21, 2004
    Posted
    October 5, 2004
    Terminated
    December 15, 2004
    Address
    Newark, DE, 19702

    Description

    BC Thrombin Reagent . Thrombin Time Test

    Reason

    The product does not demonstrate the expected prolonged thrombin times for specimens obtained from patients recieving heparin

    Action

    The recalling firm issued a recall letter dated 7/21/04 to their accounts informing them of the problem and the need to discard the product.

    Distribution

    The products were shipped to medical facilities in CT, FL, IA, IL, NJ, PA, and WI. The products were also shipped to Austria, Bosnia, Croatia, Hungry, Germany, Poland, Spain, RussiaFrance, Italy, Australia, Brazil, Canada, Saudi Arabia, El Salvador, and Turkey.

    Quantity

    3942 kits