Device recall
Z-1659-2025: Radiometer ABL90 Series - Radiometer ABL90 FLEX Model Number 393-090 Radiometer…
FDA device recall · Class II · Radiometer Medical ApS
Key facts
| Recall number (Z-number) | Z-1659-2025 |
|---|---|
| Recall event | 96515 |
| Product | Radiometer ABL90 Series - Radiometer ABL90 FLEX Model Number 393-090 Radiometer ABL90 Series - Radiometer ABL90 FLEX PLUS Model Number 393-092 The Radiometer ABL90 Series is a portable, automated analyzer for use in the laboratory environment, near patients or point-of-care settings. |
| Product code | CHL |
| Recalling firm | Radiometer Medical ApS |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K092686, K160153 |
| 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