FilmArray Gastrointestinal — Class II medical device recall Z-1140-2024
Ongoing recall by BioFire Diagnostics, LLC, reported 2024-02-21, distributed nationwide. Due to potential signals of increased false positive Norovirus results when using the gastrointestinal (GI) pa
| Recall number | Z-1140-2024 |
|---|---|
| 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 | 2024-01-26 |
| Classified | 2024-02-15 |
| Reported by FDA | 2024-02-21 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, AT, AU, BE, BG, BH, BM, BO, BR, CA, CH, CL, CN, CO, CR, CY, CZ, DE, DK, DO, DZ, EC, EE, EG, ES, FI, FR, GB, GR, GT, HK, HN, HR, HU, ID, IE, IL, IN, IS, IT, JO, JP, KR, KW, LB, LT, LV, MA, MX, MY, NG, NI, NL, NO, NP, NZ, OM, PA, PE, PH, PL, PT, PY, QA, RO, RS, SA, SE, SG, SI, SK, SV, TH, TN, TR, TW, UY, VE, VN, ZA |
| Reason classes | microbial contamination |
| Pathogens | norovirus |
| UPC / GTIN / UDI-DI | 00815381020109 |
| Model numbers | RFIT-ASY-0104, RFIT-ASY-0116 |
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 for recall
Due to potential signals of increased false positive Norovirus results when using the gastrointestinal (GI) panel.
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-1140-2024. 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.