Device recall
Z-0675-2018: Cobas 8000 Modular Series system; Software Version 05-02 and 06-03; UDI…
FDA device recall · Class II · Roche Diagnostics Corporation
Key facts
| Recall number (Z-number) | Z-0675-2018 |
|---|---|
| Recall event | 79046 |
| Product | Cobas 8000 Modular Series system; Software Version 05-02 and 06-03; UDI: 05641446001 |
| Product code | JJE |
| Recalling firm | Roche Diagnostics Corporation |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jun 10, 2020 |
| 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