Device recall
Z-2003-2020: Inpeco FlexLab, ARCHITECT cSystem c8000/c16000 Interface Module, Part Numbers…
FDA device recall · Class II · Inpeco S.A.
Key facts
| Recall number (Z-number) | Z-2003-2020 |
|---|---|
| Recall event | 85454 |
| Product | Inpeco FlexLab, ARCHITECT cSystem c8000/c16000 Interface Module, Part Numbers: FLX-208-00, FLX-208-10 - Product Usage: The FlexLab (aka Accelerator a3600) is a modular system designed to automate Pre-Analytical and Post-Analytical processing, sample handling in order to automate sample processing in… |
| Product code | CEM |
| Recalling firm | Inpeco S.A. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jul 28, 2022 |
| 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