BEUDAMED
    FDA Recall Terminated

    Hemoliance RecombiPlasTin. Prothrombin Time Test. The product is available as a kit of 25 vials of Hemoliance RecombiPlasTin matched with 25 vials of Hemoliance RecombiPlasTin Diluent. Hemoliance RecombiPlasTin after reconstitution with Hemoliance RecombiPlasTin Diluent is a liposomal preparation of recombinant human tissue factor and purified phospholipids, calcium chloride, buffer and a preservative. The use of recombinant human tissue factor and purified phospholipids assures uniformity in reagent purity, ISI values and performance from lot to lot. Once reconstituted, it is ready for use in the one-stage PT test. Hemoliance RecombiPlasTin Diluent is an aqueous solution of calcium chloride and a preservative. --- FOR IN VITRO DIAGNOSTIC USE.

    Recall: Z-1247-06 · Initiated March 7, 2006

    Recall

    Recall Number
    Z-1247-06
    Event Number
    35632
    Firm
    Instrumentation Laboratory Co.
    FEI Number
    1217183
    Product Code
    GJS
    Status
    Terminated
    Root Cause
    Other
    Initiated
    March 7, 2006
    Posted
    July 18, 2006
    Terminated
    August 11, 2006
    Address
    113 Hartwell Ave, Lexington, MA, 02421-3125

    Description

    Hemoliance RecombiPlasTin. Prothrombin Time Test. The product is available as a kit of 25 vials of Hemoliance RecombiPlasTin matched with 25 vials of Hemoliance RecombiPlasTin Diluent. Hemoliance RecombiPlasTin after reconstitution with Hemoliance RecombiPlasTin Diluent is a liposomal preparation of recombinant human tissue factor and purified phospholipids, calcium chloride, buffer and a preservative. The use of recombinant human tissue factor and purified phospholipids assures uniformity in reagent purity, ISI values and performance from lot to lot. Once reconstituted, it is ready for use in the one-stage PT test. Hemoliance RecombiPlasTin Diluent is an aqueous solution of calcium chloride and a preservative. --- FOR IN VITRO DIAGNOSTIC USE.

    Reason

    Firm received 2 complaints concerning incorrect prothrombin time (PT) results while using the reagents on samples of patients taking the antibiotic CUBICIN (Daptomycin for injection).

    Action

    "Urgent Product Notifications" were sent to IL customers on 3/07/06 through its distributor, Beckman Coulter.

    Distribution

    Nationwide

    Quantity

    5 mL: 3870; 20 mL: 29,007 (all Domestic)