BEUDAMED
    FDA Recall Terminated

    Cardiolipin IgM ELISA Test System, Product Number 438450CE. The test kit consists of a test plate, and various reagents in individual vials (positive and negative controls, calibrator, diluent, substrate, stop solution, wash buffer.). The individual vials are secured in the card board box. The test kit which is coated with the appropirate antigen, are placed in a foil pouch, which is also placed in the middle of the cardboard box.

    Recall: Z-0214-05 · Initiated August 30, 2004

    Recall

    Recall Number
    Z-0214-05
    Event Number
    29963
    Firm
    Zeus Scientific Inc
    FEI Number
    2242436
    Product Code
    MID
    Status
    Terminated
    Root Cause
    Other
    Initiated
    August 30, 2004
    Posted
    November 20, 2004
    Terminated
    October 3, 2006
    Address
    200 Evans Way, Somerville, NJ, 08876-3767

    Description

    Cardiolipin IgM ELISA Test System, Product Number 438450CE. The test kit consists of a test plate, and various reagents in individual vials (positive and negative controls, calibrator, diluent, substrate, stop solution, wash buffer.). The individual vials are secured in the card board box. The test kit which is coated with the appropirate antigen, are placed in a foil pouch, which is also placed in the middle of the cardboard box.

    Reason

    During packaging, Lyme plates were packaged in this kit in error.

    Action

    Wampole Laboratories was contacted by Zeus on 8/30/3004. Wampole customers were then contacted by phone and letter to destroy all products on hand.

    Distribution

    25 units were sent directly from Zeus to their direct account Wampole Laboratories. The distributor contacted their customers to discard all affected kits. 8 units were shipped overseas to Israel. There were no ships to government facilities.

    Quantity

    25 kits