Device recall
Z-2162-2012: The ABL software version 6.12 for the ABL800 analyzer. The analyzers are…
FDA device recall · Class II · Radiometer America Inc
Key facts
| Recall number (Z-number) | Z-2162-2012 |
|---|---|
| Recall event | 62503 |
| Product | The ABL software version 6.12 for the ABL800 analyzer. The analyzers are intended for the 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… |
| Product code | CHL |
| Recalling firm | Radiometer America Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Aug 20, 2013 |
| 510(k) numbers | K002290, K041874, K100777, K110416, K111897, K992859 |
| 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