Recall Z-0261-05 ยท GJS Test, Time, Prothrombin
Trinity Biotech USA
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.
| Date | Nov 30, 2004 (initiated Oct 27, 2004) |
| Status | Terminated |
| Reason | Prolongation of Prothrombin times in patient samples, resulting in a falsely elevated INR value. |
| Root cause | Other |
| 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. |
| Quantity | 1,183 kits |
| 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 Ire |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K972796 | SIGMA DIAGNOSTICS THROMBOMAX WITH CALCIUM Sigma Diagnostics, Inc., Oct 10, 1997 |