Elecsys Troponin T; catalog number 2017644
FDA device recall Z-0870-03 · posted 2003-05-29 · Terminated
Recall details
- Recalling firm
- Roche Diagnostics Corp.
- Reason for recall
- Hemoglobin interference limitation revised downward; hemolyzed samples may result in false negative results.
- Action taken
- An Urgent Product Correction letter was mailed to each account, during the week of 4/21/03, advising them not to use hemolyzed specimens with a hemoglobin level equal to, or greater than, 0.1 g/dL.
- Root cause
- Other
- Status
- Terminated
- Product code
- MMI
- Distribution
- United States
- Date initiated
- 2003-04-25
- Date posted
- 2003-05-29
- Date terminated
- 2003-06-19
- Location
- Indianapolis, IN
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ELECSYS TROPONIN T STAT TEST (K984105) | Boehringer Mannheim Corp. | 1998-12-08 |