Device recall
Z-2732-2017: Nova Biomedical Stat Profile Prime Analyzer as follows: PN 52855 Stat Profile…
FDA device recall · Class II · Nova Biomedical Corporation
Key facts
| Recall number (Z-number) | Z-2732-2017 |
|---|---|
| Recall event | 77532 |
| Product | Nova Biomedical Stat Profile Prime Analyzer as follows: PN 52855 Stat Profile Prime ABG Analyzer PN 53655 Stat Profile Prime ABG Analyzer with Scanner PN 52856 Stat Profile Prime CCS Analyzer PN 53656 Stat Profile Prime CCS Analyzer with Scanner PN 53657 Stat Profile Prime CCS Comp Analyzer with… |
| Product code | CHL |
| Recalling firm | Nova Biomedical Corporation |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Aug 14, 2018 |
| 510(k) numbers | K131703, K141907, K142220, K151982 |
| FEI number | 1219029 |
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