Device recall
Z-0231-2018: ABL800 analyzer with FLEXQ module. Device intended for in vitro testing of…
FDA device recall · Class II · Radiometer America Inc
Key facts
| Recall number (Z-number) | Z-0231-2018 |
|---|---|
| Recall event | 78445 |
| Product | ABL800 analyzer with FLEXQ module. Device intended for in vitro testing of samples of whole blood for the parameters pCO2, cK+, cNa+, cCa2+, cCl , cGlu, cLac, cCrea, ctBil, and co-oximetry parameters (ctHb, sO2, and the hemoglobin fractions FO2Hb, FCOHb, FMetHb, FHHb and FHbF) - in vitro testing of… |
| Product code | CHL |
| Recalling firm | Radiometer America Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Oct 10, 2023 |
| 510(k) numbers | K041874 |
| 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