ACCU-CHEK Inform meter; catalog No. 3035123.
FDA device recall Z-0372-05 · posted 2004-12-28 · Terminated
Recall details
- Recalling firm
- Roche Diagnostics Corp.
- Reason for recall
- A firmware bug may allow test results from other systems, recorded into the INFORM system via the OTE functionality, to be reversed from positive to negative, and vice versa.
- Action taken
- Consignees were notified via a letter dated 11/19/04, which instructed them to discontinue using the OTE functionality.
- Root cause
- Other
- Status
- Terminated
- Product code
- NBW
- Quantity affected
- 4697
- Distribution
- Nationwide.
- Date initiated
- 2004-11-19
- Date posted
- 2004-12-28
- Date terminated
- 2005-06-07
- 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 |
|---|---|---|
| MODIFICATION TO ACCU-CHEK INFORM METER (K012210) | Roche Diagnostics Corp. | 2001-08-09 |