Device recall
Z-0560-2024: Roche Cobas 8000 and Cobas PRO Interface Module (CO8 IM)- IVD FlexLab Automation…
FDA device recall · Class II · Inpeco S.A.
Key facts
| Recall number (Z-number) | Z-0560-2024 |
|---|---|
| Recall event | 93423 |
| Product | Roche Cobas 8000 and Cobas PRO Interface Module (CO8 IM)- IVD FlexLab Automation System -a modular system designed to automate Pre-Analytical and Post-Analytical processing, sample handling in order to automate sample processing in the Laboratory. Hardware versions: FLX-247-00 Firmware versions… |
| Product code | CEM |
| Recalling firm | Inpeco S.A. |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K121012 |
| FEI number | 3010825766 |
At a glance
- 1–9 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