Device recall
Z-0312-2022: BioFire Blood Culture Identification 2 (BCID2) Panel Part No: RFIT-ASY-0147 UDI…
FDA device recall · Class II · BioFire Diagnostics, LLC
Key facts
| Recall number (Z-number) | Z-0312-2022 |
|---|---|
| Recall event | 88934 |
| Product | BioFire Blood Culture Identification 2 (BCID2) Panel Part No: RFIT-ASY-0147 UDI: 00815381020338 Blood Culture Catalog No./Description: 442023/BD BACTEC Plus Aerobic medium in plastic vials 442021/BD BACTEC Lytic Anaerobic medium in plastic vials 442192//BD BACTEC Plus Aerobic medium in glass vials… |
| Product code | PEN |
| Recalling firm | BioFire Diagnostics, LLC |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Aug 10, 2023 |
| 510(k) numbers | K193519 |
| FEI number | 3002773840 |
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