Roche brand Elecsys Troponin T; catalog number 2017644.
FDA device recall Z-0512-06 · posted 2006-02-09 · Terminated
Recall details
- Recalling firm
- Roche Diagnostics Corp.
- Reason for recall
- A false negative result may be reported.
- Action taken
- Recall letter dated 1/31/06 was issued to each customer instructing them to stop using, and to discard, the product.
- Root cause
- Other
- Status
- Terminated
- Product code
- MMI
- Quantity affected
- 3116 kits
- Distribution
- Nationwide.
- Date initiated
- 2006-01-31
- Date posted
- 2006-02-09
- Date terminated
- 2006-04-10
- 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 |
|---|---|---|
| ROCHE ELECSYS TROPONIN T STAT (SHORT TURNAROUND TIME) (K051752) | Roche Diagnostics | 2005-07-11 |
| ELECSYS TROPONIN T STAT TEST (K040733) | Roche Diagnostics Corp. | 2004-05-17 |
| ELECSYS TROPONIN T STAT TEST (K984105) | Boehringer Mannheim Corp. | 1998-12-08 |