BEUDAMED
    FDA Recall Terminated

    Directigen (TM) EZ RSV In-Vitro Diagnostic test kit, containing reagents and controls for 30 tests, packaged in papercard carton. Catalog #256030.

    Recall: Z-0373-04 · Initiated December 15, 2003

    Recall

    Recall Number
    Z-0373-04
    Event Number
    27995
    Firm
    Becton Dickinson & Co.
    FEI Number
    1119779
    Product Code
    GQG
    Status
    Terminated
    Root Cause
    Other
    Initiated
    December 15, 2003
    Posted
    July 20, 2004
    Terminated
    June 21, 2004
    Address
    7 Loveton Cir, Sparks, MD, 21152-9212

    Description

    Directigen (TM) EZ RSV In-Vitro Diagnostic test kit, containing reagents and controls for 30 tests, packaged in papercard carton. Catalog #256030.

    Reason

    Diagnostic test kit may exhibit false positive results.

    Action

    The recalling firm notified consignees by fax, e-mail and letters 12/15/03. The letter advised of the false positive test results and requested end users to discontinue use and discard remaining packages for replacement. Consignees were requested to return response form.

    Distribution

    Product was sold to 242 direct account end users nationwide and 2 affiliated distributors in foreign countries.

    Quantity

    600 kits