FilmArray Gastronintestinal — Class II medical device recall Z-1451-2020
Terminated recall by BioFire Diagnostics, LLC, reported 2020-03-18, distributed in IL, KY, MS, NJ. Complaints have been received concerning elevated rates of false negative results while using the Gastrointest
| Recall number | Z-1451-2020 |
|---|---|
| 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 | 2019-08-08 |
| Classified | 2020-03-06 |
| Reported by FDA | 2020-03-18 |
| Terminated | 2022-04-12 |
| Distributed | IL, KY, MS, NJ |
| UPC / GTIN / UDI-DI | 00815381020116 |
| Lot numbers | 0537319, 681619 |
| Model numbers | 6-PACK, RFIT-ASY-0104 |
| Expiration dates | 2020-05-30 |
Product
FilmArray Gastronintestinal (GI) Panel, REF: RFIT-ASY-0104, 6-pack kit, UDI (01)00815381020116, CE IVD, Rx Only
Reason for recall
Complaints have been received concerning elevated rates of false negative results while using the Gastrointestinal (GI) Panel. False negative results may lead to incorrect treatment being provided which could potentially lead to more serious health events.
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-1451-2020. 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.