Device recall
Z-0457-2009: ABL7XX Calibration 1 Solution S1720. P/N S1720, 944-024 Intended for in vitro…
FDA device recall · Class II · Radiometer America Inc
Key facts
| Recall number (Z-number) | Z-0457-2009 |
|---|---|
| Recall event | 49468 |
| Product | ABL7XX Calibration 1 Solution S1720. P/N S1720, 944-024 Intended for in vitro testing of samples of whole blood for the parameters pH, pO2, pCO2, potassium, sodium, calcium, chloride, glucose, lactate, total bilirubin, and co-oximetry parameters (total hemoglobin, oxygen saturation, and the… |
| Product code | JFP |
| Recalling firm | Radiometer America Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Apr 25, 2012 |
| 510(k) numbers | K002290 |
| FEI number | 1523456 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 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