Device recall
Z-0608-2013: Qualicheck 1+, Aqueous Quality Control, Level 2, S7140, REF 944-042. The…
FDA device recall · Class III · Radiometer America Inc
Key facts
| Recall number (Z-number) | Z-0608-2013 |
|---|---|
| Recall event | 37530 |
| Product | Qualicheck 1+, Aqueous Quality Control, Level 2, S7140, REF 944-042. The solution is used for quality check of blood gas analyzers. |
| Product code | JJE |
| Recalling firm | Radiometer America Inc |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Feb 5, 2013 |
| 510(k) numbers | K771444 |
| 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