Device recall
Z-1856-2021: Radiometer ABL90 FLEX Analyzer with E3800 PC units. The E3800 CPU is also used…
FDA device recall · Class II · Radiometer Medical ApS
Key facts
| Recall number (Z-number) | Z-1856-2021 |
|---|---|
| Recall event | 87870 |
| Product | Radiometer ABL90 FLEX Analyzer with E3800 PC units. The E3800 CPU is also used as spare part. |
| Product code | CEM |
| Recalling firm | Radiometer Medical ApS |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K092686 |
| FEI number | 3002807968 |
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