Device recall
Z-0748-2016: AQURE System; Model Number: 933-599. The AQURE System manages blood gas and…
FDA device recall · Class II · Radiometer America Inc
Key facts
| Recall number (Z-number) | Z-0748-2016 |
|---|---|
| Recall event | 72959 |
| Product | AQURE System; Model Number: 933-599. The AQURE System manages blood gas and immunoassay analyzers. |
| Product code | CHL |
| Recalling firm | Radiometer America Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Mar 29, 2016 |
| 510(k) numbers | K130144, K142898, K151856 |
| FEI number | 3010420736 |
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