Device recall
Z-0208-2024: Nova Stat Profile Prime Plus POC Analyzer (CE)-Intended to measure certain gases…
FDA device recall · Class II · Nova Biomedical Corporation
Key facts
| Recall number (Z-number) | Z-0208-2024 |
|---|---|
| Recall event | 93095 |
| Product | Nova Stat Profile Prime Plus POC Analyzer (CE)-Intended to measure certain gases in blood, serum, plasma or pH of blood, serum, and plasma. (1) PN 63368 Stat Profile Prime Plus POC Analyzer (2) PN 63369 Stat Profile Prime Plus POC Analyzer, Remanufactured P/N: 57400, 63368 |
| Product code | JGS |
| Recalling firm | Nova Biomedical Corporation |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K200403 |
| FEI number | 1219029 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 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