Device recall
Z-2164-2012: ABL90 FLEX software version 2.7 MR3. The ABL90 FLEX analyzer is intended for in…
FDA device recall · Class II · Radiometer America Inc
Key facts
| Recall number (Z-number) | Z-2164-2012 |
|---|---|
| Recall event | 62503 |
| Product | ABL90 FLEX software version 2.7 MR3. The ABL90 FLEX analyzer is intended for in vitro testing of samples of heparinized whole blood. |
| Product code | CHL |
| Recalling firm | Radiometer America Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Aug 20, 2013 |
| 510(k) numbers | K120197 |
| FEI number | 1523456 |
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