Device recall
Z-0010-2019: ABL90 FLEX analyzers with software versions 3.3MR1 or below. The ABL90 FLEX…
FDA device recall · Class II · Radiometer America Inc
Key facts
| Recall number (Z-number) | Z-0010-2019 |
|---|---|
| Recall event | 80718 |
| Product | ABL90 FLEX analyzers with software versions 3.3MR1 or below. The ABL90 FLEX Analyzer is a portable, automated Analyzer that measures pH, blood gases, electrolytes, glucose, lactate, bilirubin and oximetry in whole blood. It is intended for use in a laboratory environment, near patient or… |
| Product code | JJE |
| Recalling firm | Radiometer America Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Nov 6, 2020 |
| 510(k) numbers | K120197 |
| FEI number | 3010420736 |
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