Device recall
Z-1346-2013: cobas 4800 system z480 instrument. Integrates fully automated total nucleic acid…
FDA device recall · Class II · Roche Molecular Systems, Inc.
Key facts
| Recall number (Z-number) | Z-1346-2013 |
|---|---|
| Recall event | 64930 |
| Product | cobas 4800 system z480 instrument. Integrates fully automated total nucleic acid isolation directly from secondary sample tubes. |
| Product code | OOI |
| Recalling firm | Roche Molecular Systems, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Aug 7, 2014 |
| FEI number | 2243471 |
At a glance
- None 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