Recall Z-0328-04 ยท JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Roche Diagnostics Corp.
Roche brand OMNI 9 clinical chemistry analyzer; catalog numbers GD0475, GD0475R and GD047591.
| Date | Jan 10, 2004 (initiated Dec 15, 2003) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Other |
| Action | 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. |
| Distribution | United States. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K972733 | AVL OMNI ANALYZER Avl Scientific Corp., Sep 9, 1997 |