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.
FDA Recall Z-0261-05 · Posted 2004-11-30
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Recalling FirmTrinity Biotech USA
Recall StatusTerminated
Product CodeGJS
Date Initiated2004-10-27
Date Terminated2005-07-25
Product Quantity1,183 kits
Reason for Recall
Prolongation of Prothrombin times in patient samples, resulting in a falsely elevated INR value.
Firm 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.
Root Cause
Other
Distribution Pattern
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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