Device recall
Z-1316-06: Package Insert which accompanies the Hematocrit and Metabolite QUALICHECK LEVEL…
FDA device recall · Class III · Radiometer America Inc
Key facts
| Recall number (Z-number) | Z-1316-06 |
|---|---|
| Recall event | 35773 |
| Product | Package Insert which accompanies the Hematocrit and Metabolite QUALICHECK LEVEL 2 Quality Control of Hematocrits and Metabolites, used with the ABL 77/70/555 Blood Gas & Electrolyte Analyzers. The QC reagents are packaged in a box of 30 glass vials of (1.5 ml) per box. The package insert is packed… |
| Product code | GKF |
| Recalling firm | Radiometer America Inc |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Feb 24, 2012 |
| 510(k) numbers | K973367, K973742 |
| 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