Device recall
Z-1393-2009: Roche cobas 6000 analyzer series (including cobas c 501 and cobas e 601 modules)…
FDA device recall · Class II · Roche Diagnostics Corp.
Key facts
| Recall number (Z-number) | Z-1393-2009 |
|---|---|
| Recall event | 51561 |
| Product | Roche cobas 6000 analyzer series (including cobas c 501 and cobas e 601 modules) Middleware Solutions Instrument Manager Standard as follows: v.8.04.02.10, catalog no. 04785550001; v.8.04.03, catalog no. 04785550002; and v.8.06.02, catalog no. 05108993001. The device is used to interface hospital… |
| Product code | JQP |
| Recalling firm | Roche Diagnostics Corp. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Dec 7, 2009 |
| FEI number | 1823260 |
At a glance
- None 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