Device recall
Z-0587-2017: FlexLab, Accelerator a3600 and Aptio Automation are modular systems designed to…
FDA device recall · Class II · Inpeco S.A.
Key facts
| Recall number (Z-number) | Z-0587-2017 |
|---|---|
| Recall event | 75513 |
| Product | FlexLab, Accelerator a3600 and Aptio Automation are modular systems designed to automate Pre-Analytical and Post-Analytical processing, sample handling in order to automate sample processing in the Laboratory. The systems consolidate multiple Analytical instruments into a unified workstation. |
| Product code | CEM |
| Recalling firm | Inpeco S.A. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | May 31, 2019 |
| 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