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. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
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.
Brand
Trinity Biotech USA
Lot Codes / Batch Numbers
M13906, Exp. 6/14/06
Products Sold
M13906, Exp. 6/14/06
Trinity Biotech USA is recalling AMAX ThromboMAX with Calcium, 10x4ml vials. Catalog #T9902. Lyophilized extract of rabbit brain wi due to Prolongation of Prothrombin times in patient samples, resulting in a falsely elevated INR value.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Prolongation of Prothrombin times in patient samples, resulting in a falsely elevated INR value.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026