Device recall
Z-2764-2019: Viva-ProE Systems, Model # 6003-670, UDI: 03661540600357 - Product Usage: The…
FDA device recall · Class III · ELITech Group B.V.
Key facts
| Recall number (Z-number) | Z-2764-2019 |
|---|---|
| Recall event | 83381 |
| Product | Viva-ProE Systems, Model # 6003-670, UDI: 03661540600357 - Product Usage: The ELITech Clinical Systems Selectra ProM is an automated clinical chemistry system intended for use in clinical laboratories. It is intended to be used for a variety of assay methods that have been applied to… |
| Product code | JJE |
| Recalling firm | ELITech Group B.V. |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Feb 4, 2022 |
| 510(k) numbers | K102647 |
| FEI number | 3001576181 |
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