FilmArray® Gastrointestinal (GI) Panel RFIT-ASY-0104Recalls & reported problems

Biofire Diagnostics, LLC · IVD reagent kit containing 6 tests. · Class 2

All models of FilmArray Gastrointestinal (GI) Panel (2)

Data updated Oct 18, 2026 from official FDA records · Editorial policy

1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.

Adverse event reports: 0
Deaths reported: 0
Injuries reported: 0
Recalls naming it: 1

Summary

No MAUDE adverse event reports in our data reference this device identifier directly.

1 FDA recall record name this device's identifier, 1 still open.

7 other recalls cover devices cleared under the same FDA submission (K140407, K143005, K160459, K230404, K242367); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Recalls naming this device

Apr 25, 2023Class IIOpen, Classified
The firm has identified an increased risk of obtaining false positive Cryptosporidium results from customers using the BIOFIRE FILMARRAY Gastrointestinal (GI) Panel
Z-2588-2023 · Root cause: Software design · Recall details · FDA record ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K140407, K143005, K160459, K230404, K242367. One submission often covers many models, so check the product and lot details in each record.

Z-2514-2024 · May 16, 2024 · Open, Classified
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
Z-1140-2024 · Jan 26, 2024 · Open, Classified
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 diagnosti
Z-0703-2024 · Nov 27, 2023 · Open, Classified
BIOFIRE FILMARRAY Gastrointestinal (GI) Panel is a qualitative multiplexed nucleic acid-based in vitro diagnostic test intended for use with BIOFIRE FILMARRAY Systems.
Z-1392-2023 · Mar 8, 2023 · Open, Classified
FilmArray Gastrointestinal (GI) Panel for FILMARRAY Systems, REF: RFIT-ASY-0116, (30 pouches/kit)
Z-1253-2023 · Feb 1, 2023 · Open, Classified
In Vitro Diagnostic (IVD) Panel FilmArray GI Panel - REF RFIT-ASY-0116
Z-1451-2020 · Aug 8, 2019 · Terminated
FilmArray Gastronintestinal (GI) Panel, REF: RFIT-ASY-0104, 6-pack kit, UDI (01)00815381020116, CE IVD, Rx Only
Z-1242-2019 · Mar 6, 2019 · Terminated
FilmArray Gastrointestinal (GI) Panel, IVD, Rx Only, Biofire Diagnostics, LLC REF: RFIT-ASY-0104, and RFIT-ASY-0116), Product Usage: The FilmArray Gastrointestinal (GI) Pane

Device details

UDI-DI	`00815381020116`
Brand	FilmArray® Gastrointestinal (GI) Panel
Model	RFIT-ASY-0104
Company	Biofire Diagnostics, LLC
Product code	PCH · Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-Based Assay System
Class	Class 2
FDA submission	K140407, K143005, K160459, K230404, K242367
Implant	No
Rx / OTC	Prescription
Single use	Yes
Sterile	No
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Feb 6, 2025

Device type (GMDN): Multiple-type gastrointestinal pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)

A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of nucleic acid from multiple types of microorganisms associated with gastrointestinal disease, in a clinical specimen, using a nucleic acid technique (NAT). Microorganisms detected may include bacteria, viruses, fungi and/or parasites such as, but are not limited to Salmonella, Shigella, Campylobacter, Escherichia coli (E. coli), Norovirus, Rotavirus, Clostridium difficile, Giardia, Bacillus and/or Vibrio species.

Other Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-Based Assay System devices

FilmArray® Gastrointestinal (GI) Panel RFIT-ASY-0116
Biofire Diagnostics, LLC · Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-Based Assay System
6 recalls2 deaths24 reports
BD MAX™ Enteric Bacterial Panel 442963
Becton, Dickinson And Company · Gastrointestinal pathogen panel multiplex nucleic acid-based assay system
2 recalls102 reports
BD MAX™ Extended Enteric Bacterial Panel 443812
Becton, Dickinson And Company · Gastrointestinal pathogen panel multiplex nucleic acid-based assay system
1 recall114 reports
BD MAX™ Enteric Parasite Panel 442960
Becton, Dickinson And Company · Gastrointestinal pathogen panel multiplex nucleic acid-based assay system
1 recall70 reports
Enteric Pathogens (EP) Stool Sample Preparation Kit 30-002-023
Luminex Corporation · Gastrointestinal pathogen panel multiplex nucleic acid-based assay system
2 recalls1 report
xTAG® Gastrointestinal Pathogen Panel (GPP) I032C0316
Luminex Molecular Diagnostics, Inc · Gastrointestinal pathogen panel multiplex nucleic acid-based assay system
1 recall0 reports

All Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-Based Assay System devices →

Sources and updates

Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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