Roche ISE Internal Standard Gen.2 for use on Roche cobas c systems, Roche Diagnostics, Inc., Indpls., IN; Catalog no. 04
FDA device recall Z-0542-2009 · posted 2009-01-06 · Terminated
Recall details
- Recalling firm
- Roche Diagnostics Corp.
- Reason for recall
- Test results, low: Sodium, potassium and chloride results on the cobas 6000 ISE unit may exhibit a downward drift in controls and patient samples within the recommended calibration interval of 24 hours. For further information, please contact Roche Diagnostics Corporation by telephone at 800-428-2336.
- Action taken
- Consignees were notified by letter dated 9/15/08, which provided a work-around for them to use until the problem can be permanently resolved. The letter was entitled "URGENT MEDICAL DEVICE CORRECTION." For further information, please contact Roche Diagnostics Corporation by telephone at 800-428-2336.
- Root cause
- Package design/selection
- Status
- Terminated
- Product code
- JIX
- Quantity affected
- 7909
- Distribution
- Nationwide Distribution.
- Date initiated
- 2008-09-15
- Date posted
- 2009-01-06
- Date terminated
- 2009-12-01
- 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 |
|---|---|---|
| COBAS 6000 SERIES SYSTEM (K060373) | Roche Diagnostics | 2006-03-13 |