BEUDAMED
    FDA Recall Terminated

    EL-aCL Anti-Cardiolipin ELISA Kit; an in-vitro diagnostic anticardiolipin immunological test system; 192 tests per kit; catalog #201-204; Thera Test Laboratories Inc., 1111 North Main Street, Lombard, IL 60148

    Recall: Z-0835-06 · Initiated January 11, 2006

    Recall

    Recall Number
    Z-0835-06
    Event Number
    34945
    Firm
    Thera Test Laboratories, Inc.
    FEI Number
    1421346
    Product Code
    MID
    Status
    Terminated
    Root Cause
    Other
    Initiated
    January 11, 2006
    Posted
    May 4, 2006
    Terminated
    May 3, 2006
    Address
    1111 N Main St, Lombard, IL, 60148-1360

    Description

    EL-aCL Anti-Cardiolipin ELISA Kit; an in-vitro diagnostic anticardiolipin immunological test system; 192 tests per kit; catalog #201-204; Thera Test Laboratories Inc., 1111 North Main Street, Lombard, IL 60148

    Reason

    The specimen diluent contained in the kits was contaminated with a fungal growth. Also, a portion of kit lot 09055514 was shipped without the Data Sheet, part #201-204.

    Action

    On 10/26/05, Thera Test telephoned the 3 accounts who received lot 09055514 without the Data Sheet in the kits, and sent them copies of the Data Sheet for insertion into the 6 kits on hand at the consignees. Between 1/4-9/06, Thera Test telephoned the 17 accounts receiving kit lots 09055514 and 12055603, and sent them follow-up letters dated 1/9/06 with replacement bottles of Specimen Diluent. The accounts were advised of the fungal contamination found in some bottles of the diluent shipped with the kit lots, and were requested to destroy any remaining bottles of the Specimen Diluent in their kits and replace them with the bottles of diluent sent with the letter.

    Distribution

    California, Connecticut, Maryland, Pennsylvania, Ohio, New Jersey and Florida.

    Quantity

    53 kits