COBAS INTEGRA Creatinine Jaffe for use on the INTEGRA 400, 700 and 800 analyzers; system ID # 0764345, catalog # 2076434
FDA device recall Z-0667-03 · posted 2003-03-21 · Terminated
Recall details
- Recalling firm
- Roche Diagnostics Corp.
- Reason for recall
- After a cassette change, patient results and controls may be up to 40% too low or too high due to calibration factor variation.
- Action taken
- An urgent product removal bulletin dated 2/14/03 was sent to each affected customer advising them to discontinue use of this lot, to discard any product on hand, and to contact Roche for replacement.
- Root cause
- Other
- Status
- Terminated
- Quantity affected
- 1905
- Distribution
- United States
- Date initiated
- 2003-02-13
- Date posted
- 2003-03-21
- Date terminated
- 2003-03-20
- 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 COBAS INTEGRA ANALYZER, REAGENT CASSETTES (K951595) | Roche Diagnostic Systems, Inc. | 1995-09-08 |