Z-0261-05

AMAX ThromboMAX with Calcium, 10x4ml vials. Catalog #T9902. Lyophilized extract of rabbit brain with buffer...

Name: Z-0261-05 AMAX ThromboMAX with Calcium, 10x4ml vials. Catalog #T9902. Lyophilized extract of rabbit brain with buffer...
Creator: Trinity Biotech USA
Published: 2004-10-27
License: https://open.fda.gov/license/

Trinity Biotech USA / initiated 2004-10-27 / Terminated

FDA source

Trinity Biotech USA began a recall of AMAX ThromboMAX with Calcium, 10x4ml vials. Catalog #T9902. Lyophilized extract of rabbit brain with buffer, stabilizers and calcium chloride. Responsible firm... on 2004-10-27. The reason FDA records is "Prolongation of Prothrombin times in patient samples, resulting in a falsely elevated INR value". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0261-05
Status: Terminated
Initiated: 2004-10-27
Posted: 2004-11-30
Terminated: 2005-07-25
Recalling firm: Trinity Biotech USA
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.
Product code: GJS Test, Time, Prothrombin
Reason for recall: Prolongation of Prothrombin times in patient samples, resulting in a falsely elevated INR value.
FDA 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 in commerce: 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 Ireland sold additional units of this lot to other countries.
Product codes and lots: M13906, Exp. 6/14/06

Product code GJS

K972796Class IISigma Diagnostics Thrombomax with CalciumSigma Diagnostics, Inc. / cleared 1997-10-10

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)