Device recall
Z-3237-2017: AutoCheck5+, Level 2, specifically designed for Radiometer Americas blood gas…
FDA device recall · Class II · Radiometer America Inc
Key facts
| Recall number (Z-number) | Z-3237-2017 |
|---|---|
| Recall event | 78097 |
| Product | AutoCheck5+, Level 2, specifically designed for Radiometer Americas blood gas analyzers The QUALICHECK+ quality control (QC) ampoules are specifically designed for Radiometer America s blood gas analyzers |
| Product code | JJS |
| Recalling firm | Radiometer America Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Aug 1, 2019 |
| 510(k) numbers | K980135 |
| FEI number | 3010420736 |
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