BEUDAMED
    FDA Recall Terminated

    Lp(a) Calibrator, Cat No. 998-41491, 1 ml glass bottles, in cardboard box, 2 bottles/box ,Waco Chemicals USA, Inc., 1600 Bellwood Road Richmond, VA 23237, Manufactured by: Wako Pure Chemical Industries, Ltd. Osaka Japan

    Recall: Z-1409-06 · Initiated July 6, 2006

    Recall

    Recall Number
    Z-1409-06
    Event Number
    35885
    Firm
    Wako Chemicals, USA Inc
    FEI Number
    3005625991
    Product Code
    MMY
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    July 6, 2006
    Posted
    August 25, 2006
    Terminated
    September 14, 2006
    Address
    1600 Bellwood Road, Richmond, VA, 23237-1326

    Description

    Lp(a) Calibrator, Cat No. 998-41491, 1 ml glass bottles, in cardboard box, 2 bottles/box ,Waco Chemicals USA, Inc., 1600 Bellwood Road Richmond, VA 23237, Manufactured by: Wako Pure Chemical Industries, Ltd. Osaka Japan

    Reason

    Unexpected low cholesterol results-The Cholesterol calibrator (Lp(a)) component of the in vitro diagnostic kit for cholesterol testing, has provided patient results lower than the correct value.

    Action

    The recalling firm notified consignees by phone and e-mail with an attached letter dated 07/06/06. The notification, flagged as ''Important Device Recall'' advised consignees to stop using the recalled product and that Lp(a) results showed a decrease in value of approximately 10% when the identified lots are used. Consignees were requested to return the enclosed response form for replacement product.

    Distribution

    The product was sold to one distributor and direct medical accounts Nationwide.

    Quantity

    136 kits