BEUDAMED
    FDA Recall Terminated

    Anti-Cardiolipin IgA ELISA test kit. Product is manufactured by Zeus Scientific, Branchburg, NJ for Sigma Diagnostics, Inc., Saint Louis, MO.

    Recall: Z-1147-03 · Initiated June 22, 2001

    Recall

    Recall Number
    Z-1147-03
    Event Number
    26578
    Firm
    Zeus Scientific Inc
    FEI Number
    2242436
    Product Code
    MID
    Status
    Terminated
    Root Cause
    Other
    Initiated
    June 22, 2001
    Posted
    August 21, 2003
    Terminated
    August 20, 2003
    Address
    200 Evans Way, Branchburg, NJ, 08876

    Description

    Anti-Cardiolipin IgA ELISA test kit. Product is manufactured by Zeus Scientific, Branchburg, NJ for Sigma Diagnostics, Inc., Saint Louis, MO.

    Reason

    Bacterial contamination of the high positive control.

    Action

    Recall letter were sent via DHL to consignee on 6/22/2001 which instructed to return or discard any remaining inventory.

    Distribution

    All product was shipped to St. Louis, MO

    Quantity

    130