FDA Device recall Z-1140-2024
FilmArray Gastrointestinal (GI) Panel RFIT-ASY-0116 (30 test kit) RFIT-ASY-0104 (6 test kit) Gastrointestinal microorganism multiplex nucle…
- FDA Device
- Class II
- ongoing
- Published 2024-02-21
On 2024-02-21 the FDA classified a Class II recall of FilmArray Gastrointestinal (GI) Panel RFIT-ASY-0116 (30 test kit) RFIT-ASY-0104 (6 test kit) Gastrointestinal microorganism multiplex nucle… by Biofire Diagnostics, citing due to potential signals of increased false positive Norovirus results when using the gastrointestinal (GI) panel.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1140-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-01-26 |
| Published | 2024-02-21 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Biofire Diagnostics |
| Distribution | US |
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.
Reason
Due to potential signals of increased false positive Norovirus results when using the gastrointestinal (GI) panel.
Identifiers
| code_info | Part No.: RFIT-ASY-0116 (30 test kit) UDI-DI code: 00815381020109 Part No. RFIT-ASY-0104 (6 test kit) UDI-DI code: 0081538102011 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1140-2024%22
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