BEUDAMED
    FDA Recall Terminated

    DIFCO Laboratories, FA Streptococcus Group A, 5mL, Catalog Number: 223181, Lot number: 6122656, Exp: 20090705, in vitro diagnostic.

    Recall: Z-1319-2008 · Initiated August 8, 2007

    Recall

    Recall Number
    Z-1319-2008
    Event Number
    46759
    Firm
    BD Diagnostic Systems Lee Laboratories
    FEI Number
    1025402
    Product Code
    GTQ
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    August 8, 2007
    Posted
    September 11, 2008
    Terminated
    March 24, 2009
    Address
    1475 Athens Hwy, Grayson, GA, 30017-1538

    Description

    DIFCO Laboratories, FA Streptococcus Group A, 5mL, Catalog Number: 223181, Lot number: 6122656, Exp: 20090705, in vitro diagnostic.

    Reason

    Incorrect result: The product exhibited decreased fluorescence when testing with the homologous control organism.

    Action

    Becton Dickinson (BD) Diagnostic Systems sent an Urgent product recall letter, dated August 2007, to all consignees, directing them to discard this lot of product. BD instructed distributors to discontinue distribution and discard any remaining product in inventory. BD requested the distributors provide an Excel file or a customer list containing the name, address and telephone number of end-users who were shipped the product. BD provided alternative testing methods. A response form was included to verify receipt of notification.

    Distribution

    Nationwide Distribution and Canada

    Quantity

    26 units