BEUDAMED
    FDA Recall Terminated

    Rubella IgM ELISA Test Kit. It is an enzyme-linked immunoabsorbent assay designed for the qualitative detection of IgM antibodies to Rubella virus in human serum. 1 kit (96 tests). Prepared for Sigma Diagnostics, Inc., St. Louis, MO 63178. EIA514-B

    Recall: Z-1065-03 · Initiated February 24, 2000

    Recall

    Recall Number
    Z-1065-03
    Event Number
    26562
    Firm
    Zeus Scientific Inc
    FEI Number
    2242436
    Product Code
    LFX
    Status
    Terminated
    Root Cause
    Other
    Initiated
    February 24, 2000
    Posted
    July 30, 2003
    Terminated
    October 25, 2004
    Address
    200 Evans Way, Branchburg, NJ, 08876

    Description

    Rubella IgM ELISA Test Kit. It is an enzyme-linked immunoabsorbent assay designed for the qualitative detection of IgM antibodies to Rubella virus in human serum. 1 kit (96 tests). Prepared for Sigma Diagnostics, Inc., St. Louis, MO 63178. EIA514-B

    Reason

    The high positive control/low positive standard ratio recovering too low.

    Action

    Recall letters sent out via DHL on 2/24/2000

    Distribution

    The two lots were shipped to St. Louis, MO. No subrecall was initiated.

    Quantity

    205