Device recall
Z-0910-2018: cobas 8000 Modular Analyzer Series; Part Numbers: 1. 05964067001 cobas 8000 c…
FDA device recall · Class II · Roche Diagnostics Corporation
Key facts
| Recall number (Z-number) | Z-0910-2018 |
|---|---|
| Recall event | 79130 |
| Product | cobas 8000 Modular Analyzer Series; Part Numbers: 1. 05964067001 cobas 8000 c 502 module |
| Product code | JJE |
| Recalling firm | Roche Diagnostics Corporation |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jul 13, 2018 |
| 510(k) numbers | K100853 |
| 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