Device recall
Z-0361-2019: FlexLab (FLX), Accelerator a3600 (ACP), Aptio Automation (AP2) (same product)…
FDA device recall · Class II · Inpeco S.A.
Key facts
| Recall number (Z-number) | Z-0361-2019 |
|---|---|
| Recall event | 81124 |
| Product | FlexLab (FLX), Accelerator a3600 (ACP), Aptio Automation (AP2) (same product) FlexLab, Accelerator a3600 and Aptio Automation are modular systems designed to automate Pre- Analytical and Post-Analytical processing, |
| Product code | JQP |
| Recalling firm | Inpeco S.A. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Mar 19, 2020 |
| 510(k) numbers | K121012 |
| FEI number | 3010825766 |
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