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.
This recall has been terminated (originally issued November 30, 2004).
- Company
- Trinity Biotech Usa
- Recall Initiated
- October 27, 2004
- Posted
- November 30, 2004
- Terminated
- July 25, 2005
- Recall Number
- Z-0261-05
- Quantity
- 1,183 kits
- Firm Location
- Jamestown, NY
- Official Source
- View on FDA website ↗
Reason for Recall
Prolongation of Prothrombin times in patient samples, resulting in a falsely elevated INR value.
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.
Lot / Code Info
M13906, Exp. 6/14/06
Root Cause
Other
Action Taken
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.