Device recall
Z-2975-2020: Aptio Automation systems with Sysmex XN-9000/XN-9100 Interface Module (dual…
FDA device recall · Class II · Inpeco S.A.
Key facts
| Recall number (Z-number) | Z-2975-2020 |
|---|---|
| Recall event | 86263 |
| Product | Aptio Automation systems with Sysmex XN-9000/XN-9100 Interface Module (dual robot) FLX-290-10; FLX-290-20 and Track to Rack Module FLX-295-10- Intended Clinical Chemistry Test Systems - Product Usage: The FlexLab 3.6 Automation is a modular system designed to automate Pre-Analytical and… |
| Product code | CEM |
| Recalling firm | Inpeco S.A. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Dec 2, 2021 |
| 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