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U.S. Department of Health and Human Services

Class 2 Device Recall ThromboMAX with Calcium

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 Class 2 Device Recall ThromboMAX with Calciumsee related information
Date Initiated by FirmOctober 27, 2004
Date PostedNovember 30, 2004
Recall Status1 Terminated 3 on July 25, 2005
Recall NumberZ-0261-05
Recall Event ID 30354
510(K)NumberK972796 
Product Classification Test, Time, Prothrombin - Product Code GJS
ProductAMAX 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.
Code Information M13906, Exp. 6/14/06
FEI Number 1318354
Recalling Firm/
Manufacturer		 Trinity Biotech USA
2823 Girts Rd
Jamestown NY 14701-9666
For Additional Information ContactVicki Lehman
800-325-3424 Ext. 228
Manufacturer Reason
for Recall		Prolongation of Prothrombin times in patient samples, resulting in a falsely elevated INR value.
FDA Determined
Cause 2		Other
ActionLetters 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 Commerce1,183 kits
DistributionTrinity 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.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = GJS
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