BEUDAMED
    FDA Recall Terminated

    AMAX ThromboMAX with Calcium, 10x4ml vials. Catalog #T9902. Lyophilized extract of rabbit brain with buffer, stabilizers and calcium chloride. Responsible firm on the label: Trinity Biotech PLC, IDA Business Park, Bray, County Wicklow, Ireland. USA Enquiries - Trinity Biotech USA, 1930 Innerbelt Business Center Drive, St. Louis, MO 63114, USA.

    Recall: Z-0261-05 · Initiated October 27, 2004

    Recall

    Recall Number
    Z-0261-05
    Event Number
    30354
    Firm
    Trinity Biotech USA
    FEI Number
    1318354
    Product Code
    GJS
    Status
    Terminated
    Root Cause
    Other
    Initiated
    October 27, 2004
    Posted
    November 30, 2004
    Terminated
    July 25, 2005
    Address
    2823 Girts Rd, Jamestown, NY, 14701-9666

    Description

    AMAX ThromboMAX with Calcium, 10x4ml vials. Catalog #T9902. Lyophilized extract of rabbit brain with buffer, stabilizers and calcium chloride. Responsible firm on the label: Trinity Biotech PLC, IDA Business Park, Bray, County Wicklow, Ireland. USA Enquiries - Trinity Biotech USA, 1930 Innerbelt Business Center Drive, St. Louis, MO 63114, USA.

    Reason

    Prolongation of Prothrombin times in patient samples, resulting in a falsely elevated INR value.

    Action

    Letters dated 11/1/2004 with instructions to (1) Discard remaining kits; (2) notify end-users; (3) Evaluate patient records when the kits were used to monitor Oral Anti-coagulant Therapy.

    Distribution

    Trinity Biotech, Jamestown, NY sold product to 87 customers: 10 distributors (7 in U.S. & 3 foreign); 1 exporter; and 76 end users. 84 of those customers are located in the United States. There is one consignee in Canada, one in Brazil, and one in Venezuela. In addition, the manufacturer in Ireland sold additional units of this lot to other countries.

    Quantity

    1,183 kits