Device recall
Z-2597-2014: RADIANCE v. 2.4X, 2.5X and 2.6X Product Usage: RADIANCE is a data processing…
FDA device recall · Class II · Radiometer America Inc
Key facts
| Recall number (Z-number) | Z-2597-2014 |
|---|---|
| Recall event | 68982 |
| Product | RADIANCE v. 2.4X, 2.5X and 2.6X Product Usage: RADIANCE is a data processing application for clinical use intended to monitor, collect, store, retrieve and process laboratory data. RADIANCE is also intended to control clinical analyzers providing laboratory data. |
| Product code | JQP |
| Recalling firm | Radiometer America Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Oct 15, 2014 |
| FEI number | 1523456 |
At a glance
- None 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