AxSYM Troponin-I Reagent Kit, list 3C29-20, 100 test kit; Abbott Laboratories, Abbott Park, IL 60064
FDA device recall Z-0782-04 · posted 2004-07-20 · Terminated
Recall details
- Recalling firm
- Abbott Laboratories HPD/ADD/GPRD
- Reason for recall
- An increase in complaints of higher than normal patient results, some from the healthy population range to above the diagnostic cutoff for an Acute Myocardial Infarction.
- Action taken
- Recalled by telephone calls on 3/26/04 and a follow-up letter dated 3/25/04. The accounts were informed of the elevated patient results for the Troponin-I Reagent lots, and were requested to discontinue use and destroy any of the four affected lots found in inventory.
- Root cause
- Other
- Status
- Terminated
- Product code
- MMI
- Quantity affected
- 7,394 kits
- Distribution
- Nationwide and internationally to Abbott affiliates in Argentina, Canada, Germany, Singapore, Hong Kong, Taiwan, Australia, New Zealand, Thailand, China and Korea.
- Date initiated
- 2004-03-26
- Date posted
- 2004-07-20
- Date terminated
- 2004-10-14
- Location
- Abbott Park, IL
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ABBOTT AXSYM TROPONIN-I (K974103) | Abbott Laboratories | 1997-11-25 |