Device recall
Z-2494-2020: Blood gases (PCO2, PO2) and blood pH test system; ABL800 FLEX; Model Number…
FDA device recall · Class II · Radiometer Medical ApS
Key facts
| Recall number (Z-number) | Z-2494-2020 |
|---|---|
| Recall event | 85700 |
| Product | Blood gases (PCO2, PO2) and blood pH test system; ABL800 FLEX; Model Number 393-801; UDI (01)05700693938011. Model 393-801 is available as ABL837. The FlexQ module is optional and can be added to all models and configurations. |
| Product code | CHL |
| Recalling firm | Radiometer Medical ApS |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Feb 8, 2023 |
| 510(k) numbers | K041874 |
| FEI number | 3002807968 |
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