Device recall
Z-0157-2020: Selectra ProM Analyzer, Catalog # 6003-435/UDI # 03661540600395 and Catalog #…
FDA device recall · Class II · Vital Scientific N.V.
Key facts
| Recall number (Z-number) | Z-0157-2020 |
|---|---|
| Recall event | 83582 |
| Product | Selectra ProM Analyzer, Catalog # 6003-435/UDI # 03661540600395 and Catalog # 6003-436/UDI # 03661540600401 Product Usage: :clinical chemistry system intended for use in clinical laboratories. |
| Product code | JGS |
| Recalling firm | Vital Scientific N.V. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Apr 19, 2024 |
| 510(k) numbers | K102647 |
| FEI number | 2708 |
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