BEUDAMED
    FDA Recall Terminated

    APhL HRP IgG & IgM ELISA Kit; Ref. #LAPL-K-HRP-00GM; in vitro diagnostic. Distributed by Louisville APL Diagnostics, Inc., Doraville, GA 30360 (address now in Seabrook, TX 77856).

    Recall: Z-0034-2008 · Initiated July 18, 2006

    Recall

    Recall Number
    Z-0034-2008
    Event Number
    39412
    Firm
    Louisville Apl Diagnostics Inc
    FEI Number
    1000305932
    Product Code
    MID
    Status
    Terminated
    Root Cause
    Process design
    Initiated
    July 18, 2006
    Posted
    October 4, 2007
    Terminated
    October 24, 2007
    Address
    2622 Nasa Pkwy, Ste G2, Seabrook, TX, 77586-3447

    Description

    APhL HRP IgG & IgM ELISA Kit; Ref. #LAPL-K-HRP-00GM; in vitro diagnostic. Distributed by Louisville APL Diagnostics, Inc., Doraville, GA 30360 (address now in Seabrook, TX 77856).

    Reason

    Product mislabeled; outer container labeled with incorrect lot number.

    Action

    Firm sent replacement labels to consignee via FedEx on 07/18/06 with instructions for consignee to change the labels on the kit boxes before shipping kits to end users.

    Distribution

    Product was shipped to a distributor in Canada.

    Quantity

    3 test kits (each kit containing 1 IgG and 1 IgM test kit)