BEUDAMED
    FDA Recall Terminated

    APhL HRP IgG & IgM ELISA Kit; Ref. #LAPL-K-HRP-00GM; distributed by Louisville APL Diagnostics, Inc., Doraville, GA 30360- Quality Control Fact Sheets for the Louisville APL Diagnostics, Inc. (address now in Seabrook, TX 77586).

    Recall: Z-1175-2007 · Initiated October 6, 2005

    Recall

    Recall Number
    Z-1175-2007
    Event Number
    38396
    Firm
    Louisville Apl Diagnostics Inc
    FEI Number
    1000305932
    Product Code
    MID
    Status
    Terminated
    Root Cause
    Other
    Initiated
    October 6, 2005
    Posted
    August 17, 2007
    Terminated
    October 11, 2007
    Address
    2622 Nasa Pkwy, Ste G2, Seabrook, TX, 77586-3447

    Description

    APhL HRP IgG & IgM ELISA Kit; Ref. #LAPL-K-HRP-00GM; distributed by Louisville APL Diagnostics, Inc., Doraville, GA 30360- Quality Control Fact Sheets for the Louisville APL Diagnostics, Inc. (address now in Seabrook, TX 77586).

    Reason

    Mislabeing : Errors (control values) identified in the QC Fact Sheet for a specific lot of APhL HRP IgG and IgM test kits.

    Action

    Firm notified consignees of recall via fax on 05/05-06/2005. Consignees asked to replace Quality Control Fact Sheets shipped with test kits with the corrected Quality Control Fact Sheets provided with fax.

    Distribution

    World Wide: Product distributed to direct accounts in CA, FL and GA. Foreign consignees located in Canada and Turkey.

    Quantity

    29 test kits (ea. kit containing 1 IgG and 1 IgM test kit)