FilmArray Gastrointestinal — Class II medical device recall Z-1242-2019
Terminated recall by BioFire Diagnostics, LLC, reported 2019-05-08, distributed nationwide. Elevated rates of false positive results for Campylobacter and Cryptosporidium have been identified.
| Recall number | Z-1242-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | BioFire Diagnostics, LLC, Salt Lake City, UT, United States |
| Recall initiated | 2019-03-06 |
| Classified | 2019-04-26 |
| Reported by FDA | 2019-05-08 |
| Terminated | 2022-02-18 |
| Distributed | Nationwide (US) |
| Countries outside the US | AR, AT, AU, BD, BE, BG, BH, BM, BR, CA, CH, CL, CO, CR, CZ, DE, DK, DZ, EC, EE, EG, ES, FR, GB, GR, GT, HK, HR, HT, HU, IL, IN, IQ, IT, JO, JP, KE, KR, KW, LB, MA, MT, MX, MY, NI, NL, OM, PA, PE, PH, PK, PL, PT, QA, RO, RS, SA, SE, SG, SI, SK, SV, TH, TR, UY, VN, ZA |
| Quantity | 17,188 |
| Model numbers | RFIT-ASY-0104, RFIT-ASY-0116 |
| Expiration dates | 2019-10-23 |
Product
FilmArray Gastrointestinal (GI) Panel, IVD, Rx Only, Biofire Diagnostics, LLC REF: RFIT-ASY-0104, and RFIT-ASY-0116), Product Usage: The FilmArray Gastrointestinal (GI) Panel is a qualitative multiplexed nucleic acid-based in vitro diagnostic test intended for use with FilmArray systems.
Reason for recall
Elevated rates of false positive results for Campylobacter and Cryptosporidium have been identified.
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-1242-2019. 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.