Device recall
Z-2609-2025: FilmArray NGDS Warrior Panel NGDS-ASY-0007 is a qualitative, multiplexed…
FDA device recall · Class II · Biofire Defense
Key facts
| Recall number (Z-number) | Z-2609-2025 |
|---|---|
| Recall event | 97286 |
| Product | FilmArray NGDS Warrior Panel NGDS-ASY-0007 is a qualitative, multiplexed, nucleic acid-based in vitro diagnostic test intended for use with the FilmArray 2.0 system. |
| Product code | PRD |
| Recalling firm | Biofire Defense |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K170883 |
| FEI number | 3010770794 |
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