Device recall
Z-1684-2020: ABL800 FLEX, model number/UDI 393-800/0570 In Vitro testing of samples of whole…
FDA device recall · Class II · Radiometer Medical ApS
Key facts
| Recall number (Z-number) | Z-1684-2020 |
|---|---|
| Recall event | 85168 |
| Product | ABL800 FLEX, model number/UDI 393-800/0570 In Vitro testing of samples of whole blood for the parameters pH, pO2, 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 Medical ApS |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Oct 31, 2022 |
| 510(k) numbers | K041874 |
| 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