Device recall
Z-2114-2020: FlexLab Automation System used with the following Modules: High Volume…
FDA device recall · Class II · Inpeco S.A.
Key facts
| Recall number (Z-number) | Z-2114-2020 |
|---|---|
| Recall event | 85537 |
| Product | FlexLab Automation System used with the following Modules: High Volume Storage(P/N FLX-270, FLX-271, FLX-276, FLX-282, FLX-283), HSQ Interface Module (P/N FLX-274), Aliquoter Module (P/N FLX-209), Rack Output Module ROM400 (P/N FLX-289), XN-9000 Interface Module (P/N FLX-290), Advia 2120 LAS… |
| Product code | CEM |
| Recalling firm | Inpeco S.A. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jun 13, 2024 |
| 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