Device recall
Z-0704-2024: The BIOFIRE Respiratory Panel 2.1 (RP2.1) is a PCR-based multiplexed nucleic…
FDA device recall · Class II · BioFire Diagnostics, LLC
Key facts
| Recall number (Z-number) | Z-0704-2024 |
|---|---|
| Recall event | 93526 |
| Product | The BIOFIRE Respiratory Panel 2.1 (RP2.1) is a PCR-based multiplexed nucleic acid test intended for use with the BIOFIRE FILMARRAY 2.0 or BIOFIRE FILMARRAY Torch Systems. |
| Product code | QOF |
| Recalling firm | BioFire Diagnostics, LLC |
| Recall class | Class II |
| Status | Open, Classified |
| FEI number | 3002773840 |
At a glance
- None 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