Device recall
Z-0353-2024: FilmArray TORCH REF HTFA-ASY-0104. HTFA-ASY-0104 is the BIOFIRE TORCH Base which…
FDA device recall · Class II · BioFire Diagnostics, LLC
Key facts
| Recall number (Z-number) | Z-0353-2024 |
|---|---|
| Recall event | 93268 |
| Product | FilmArray TORCH REF HTFA-ASY-0104. HTFA-ASY-0104 is the BIOFIRE TORCH Base which includes barcode scanner, touch screen computer and USB ports. The BioFire FilmArray Torch (BioFire Torch) is an automated in vitro diagnostic (IVD) device intended for use with FDA-cleared or approved IVD BioFire… |
| Product code | NSU |
| 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
- 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