Device recall
Z-0696-2013: Roche COBAS INTEGRA 400 and 400 plus Analyzer, an in vitro diagnostic analyzer.
FDA device recall · Class III · Roche Diagnostics Operations, Inc.
Key facts
| Recall number (Z-number) | Z-0696-2013 |
|---|---|
| Recall event | 63617 |
| Product | Roche COBAS INTEGRA 400 and 400 plus Analyzer, an in vitro diagnostic analyzer. |
| Product code | JJE |
| Recalling firm | Roche Diagnostics Operations, Inc. |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Jan 13, 2014 |
| 510(k) numbers | K951595 |
| 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