Roche brand OMNI 9 clinical chemistry analyzer; catalog numbers GD0475, GD0475R and GD047591.
FDA device recall Z-0328-04 · posted 2004-01-10 · Terminated
Recall details
- Recalling firm
- Roche Diagnostics Corp.
- Reason for recall
- If the sample volume is insufficient, the analyzer may issue erroneous results without any indication to the user that the problem is insufficient sample volume.
- Action taken
- Consignees were notified by letter mailed on or about December 15, 2003. Customers are instructed to assure an adequate sample volume until new software becomes available.
- Root cause
- Other
- Status
- Terminated
- Product code
- JJE
- Distribution
- United States.
- Date initiated
- 2003-12-15
- Date posted
- 2004-01-10
- Date terminated
- 2004-08-02
- 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 |
|---|---|---|
| AVL OMNI ANALYZER (K972733) | Avl Scientific Corp. | 1997-09-09 |