Device recall
Z-1140-2024: FilmArray Gastrointestinal (GI) Panel RFIT-ASY-0116 (30 test kit) RFIT-ASY-0104…
FDA device recall · Class II · BioFire Diagnostics, LLC
Key facts
| Recall number (Z-number) | Z-1140-2024 |
|---|---|
| Recall event | 93639 |
| Product | FilmArray Gastrointestinal (GI) Panel RFIT-ASY-0116 (30 test kit) RFIT-ASY-0104 (6 test kit) Gastrointestinal microorganism multiplex nucleic acid-based assay. In vitro diagnostic. |
| Product code | PCH |
| Recalling firm | BioFire Diagnostics, LLC |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K140407, K143005, K160459, K230404 |
| 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