AMAX ThromboMAX with Calcium, 10x4ml vials. Catalog #T9902. Lyophilized extract of rabbit brain with buffer, stabilizers
FDA device recall Z-0261-05 · posted 2004-11-30 · Terminated
Recall details
- Recalling firm
- Trinity Biotech USA
- Reason for recall
- Prolongation of Prothrombin times in patient samples, resulting in a falsely elevated INR value.
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- GJS
- Quantity affected
- 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
- Date initiated
- 2004-10-27
- Date posted
- 2004-11-30
- Date terminated
- 2005-07-25
- Location
- Jamestown, NY
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SIGMA DIAGNOSTICS THROMBOMAX WITH CALCIUM (K972796) | Sigma Diagnostics, Inc. | 1997-10-10 |