ARCHITECT STAT Troponin-I Reagent Kit, list 2K41-20; each 400 test kit contains 4 bottles each of microparticles, conjug
FDA device recall Z-0513-06 · posted 2006-02-14 · Terminated
Recall details
- Recalling firm
- Abbott Laboratories MPG
- Reason for recall
- There has been an increase in customer complaints observed for failure to calibrate or inability to generate patient result errors.
- Action taken
- Abbott sent recall letters dated 12/20/05 to the laboratory accounts via Federal Express Priority on 12/21/05. The accounts were informed of the increase in customer complaints for failure to calibrate or inability to generate patient result errors for the Troponin-I Reagent lot, and were requested to discontinue use and destroy any of the affected lot found in inventory for replacement.
- Root cause
- Other
- Status
- Terminated
- Product code
- MMI
- Quantity affected
- 181 kits
- Distribution
- Nationwide and internationally to Canada, Australia, Germany and Taiwan
- Date initiated
- 2005-12-21
- Date posted
- 2006-02-14
- Date terminated
- 2006-07-31
- 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 |
|---|---|---|
| ARCHITECT STAT TROPONIN-I IMMUNOASSAY (K041192) | Fisher Diagnostics | 2004-08-12 |