BEUDAMED
    FDA Recall Terminated

    american diagnostica inc. IgM Conjugate, 15mL; component of the american diagnostica, inc. IMUCLONE aPL IgM ELISA Kit, Product #649M; manufactured by Louisville APL Diagnostics, Inc., Seabrook, TX 77586.

    Recall: Z-1103-2007 · Initiated August 10, 2004

    Recall

    Recall Number
    Z-1103-2007
    Event Number
    38313
    Firm
    Louisville Apl Diagnostics Inc
    FEI Number
    1000305932
    Product Code
    MID
    Status
    Terminated
    Root Cause
    Other
    Initiated
    August 10, 2004
    Posted
    July 24, 2007
    Terminated
    November 27, 2007
    Address
    2622 NASA Parkway, Suite G2, Seabrook, TX, 77586-3447

    Description

    american diagnostica inc. IgM Conjugate, 15mL; component of the american diagnostica, inc. IMUCLONE aPL IgM ELISA Kit, Product #649M; manufactured by Louisville APL Diagnostics, Inc., Seabrook, TX 77586.

    Reason

    Product mislabeled; conjugate IgG placed in bottles labeled as conjugate IgM and vice versa.

    Action

    Firm notified consignee of recall via phone on 08/10/04. Consignee asked to return conjugates for properly labeled replacements.

    Distribution

    Product distributed to a single direct account in CT.

    Quantity

    35 IgM kits.