Device recall
Z-1352-06: Roche/Hitachi K Electrode, a potassium electrode for use with the Roche/Hitachi…
FDA device recall · Class II · Roche Diagnostics Corp.
Key facts
| Recall number (Z-number) | Z-1352-06 |
|---|---|
| Recall event | 35793 |
| Product | Roche/Hitachi K Electrode, a potassium electrode for use with the Roche/Hitachi models 717,747, 902, 911,912, 917, Modular and cobas c 501 clinical chemistry analyzers; Roche Catalog/Part Number 10825441001/ US # 722-4402. |
| Product code | CEM |
| Recalling firm | Roche Diagnostics Corp. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Dec 4, 2007 |
| 510(k) numbers | K953239 |
| FEI number | 1823260 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 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