BEUDAMED
    FDA Recall Terminated

    DiaSorin Anti-Cardiolipin IgA ELISA kit for the detection in human serum or plasma of antoantibodies specific for Cardiolipin IgA. Catalog No.: 7800. Manufactured for DiaSorin Inc., 1951 Northwestern Avenue, Stillwater, MN 55082-0285

    Recall: Z-0632-05 · Initiated January 23, 2004

    Recall

    Recall Number
    Z-0632-05
    Event Number
    30919
    Firm
    Diasorin Inc.
    FEI Number
    2182595
    Product Code
    MID
    Status
    Terminated
    Root Cause
    Other
    Initiated
    January 23, 2004
    Posted
    March 18, 2005
    Terminated
    July 22, 2006
    Address
    1951 Northwestern Ave S, Stillwater, MN, 55082-7536

    Description

    DiaSorin Anti-Cardiolipin IgA ELISA kit for the detection in human serum or plasma of antoantibodies specific for Cardiolipin IgA. Catalog No.: 7800. Manufactured for DiaSorin Inc., 1951 Northwestern Avenue, Stillwater, MN 55082-0285

    Reason

    DiaSorin Anti-Cardiolipin IgA kit's positive control is out of acceptable limits.

    Action

    Customers were notified via a letter which described the product and the problem. Recommended to destroy all affected kits and stated that the kits will be replaced.

    Distribution

    GA, NY & KS

    Quantity

    16 kits