FilmArray Gastrointestinal — Class II medical device recall Z-1392-2023
Ongoing recall by BioFire Diagnostics, LLC, reported 2023-04-26, distributed nationwide. Due to manufacturing issue, Gastrointestinal (GI) Panel may result in false negative results.
| Recall number | Z-1392-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | BioFire Diagnostics, LLC, Salt Lake City, UT, United States |
| Recall initiated | 2023-03-08 |
| Classified | 2023-04-14 |
| Reported by FDA | 2023-04-26 |
| Distributed | Nationwide (US) |
| UPC / GTIN / UDI-DI | 00815381020109 |
| Lot numbers | 2160422, 2N3R22 |
| Model numbers | RFIT-ASY-0116 |
Product
FilmArray Gastrointestinal (GI) Panel for FILMARRAY Systems, REF: RFIT-ASY-0116, (30 pouches/kit)
Reason for recall
Due to manufacturing issue, Gastrointestinal (GI) Panel may result in false negative results.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1392-2023. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.