BIOFIRE FILMARRAY Gastrointestinal — Class II medical device recall Z-2514-2024

Ongoing recall by BioFire Diagnostics, LLC, reported 2024-08-14, distributed nationwide. Due to increase of false positive Vibrio/Vibrio Cholerae results when using a certain transport medium.

Recall number	`Z-2514-2024`
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	2024-05-16
Classified	2024-08-06
Reported by FDA	2024-08-14
Distributed	Nationwide (US)
UPC / GTIN / UDI-DI	`00815381020109`
Lot numbers	`712258`, `732357`, `742049`, `743930`, `769240`, `782425`
Model numbers	`RFIT-ASY-0104`, `RFIT-ASY-0116`

Product

BIOFIRE FILMARRAY Gastrointestinal (GI) Panel REF RFIT-ASY-0116 (30 test kit) BIOFIRE FILMARRAY Gastrointestinal (GI) Panel REF RFIT-ASY-0104 (6 kit test) The BIOFIRE FILMARRAY Gastrointestinal (GI) Panel is a qualitative multiplexed nucleic acid-based in vitro diagnostic test intended for use with BIOFIRE¿ FILMARRAY¿ Systems. The BIOFIRE GI Panel is capable of the simultaneous detection and identification of nucleic acids from multiple bacteria, viruses, and parasites directly from stool samples in Cary Blair transport media obtained from individuals with signs and/or symptoms of gastrointestinal infection.

Reason for recall

Due to increase of false positive Vibrio/Vibrio Cholerae results when using a certain transport medium.

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-2514-2024. 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.