Device recall
Z-0425-2023: The FAST System and the FAST PBC Prep Cartridge together are a closed, rapid and…
FDA device recall · Class II · Qvella Corporation
Key facts
| Recall number (Z-number) | Z-0425-2023 |
|---|---|
| Recall event | 91130 |
| Product | The FAST System and the FAST PBC Prep Cartridge together are a closed, rapid and automated sample preparation system for isolating bacterial cells directly from a positive blood culture (PBC). The cartridge and instrument isolate and concentrate bacterial cells directly from PBC by removing blood… |
| Product code | JJH |
| Recalling firm | Qvella Corporation |
| Recall class | Class II |
| Status | Open, Classified |
| FEI number | 3013825847 |
At a glance
- None 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