Device recall
Z-1158-2020: cobas infinity core, Material No. 7154003001. The device is a calculator/data…
FDA device recall · Class II · Roche Diagnostics Operations, Inc.
Key facts
| Recall number (Z-number) | Z-1158-2020 |
|---|---|
| Recall event | 84697 |
| Product | cobas infinity core, Material No. 7154003001. The device is a calculator/data processing module, for clinical use. |
| Product code | JQP |
| Recalling firm | Roche Diagnostics Operations, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Oct 15, 2020 |
| FEI number | 1823260 |
At a glance
- None 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