Device recall
Z-0335-04: Roche brand OMNI 7 Analyzer; catalog numbers GD0435 and GD0435R.
FDA device recall · Class II · Roche Diagnostics Corp.
Key facts
| Recall number (Z-number) | Z-0335-04 |
|---|---|
| Recall event | 27989 |
| Product | Roche brand OMNI 7 Analyzer; catalog numbers GD0435 and GD0435R. |
| Product code | JJE |
| Recalling firm | Roche Diagnostics Corp. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Feb 20, 2004 |
| 510(k) numbers | K945915, K954018, K972733, K990092 |
| FEI number | 1823260 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 100–999 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database