Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-based Assay System
Microbiology · 21 CFR 866.3990
A gastrointestinal pathogen panel multiplex nucleic acid assay is a qualitative in vitro diagnostic device intended to simultaneously detect and identify multiple gastrointestinal microbial nucleic acids extracted from human stool specimens. The detection and identification of a specific gastrointestinal microbial nucleic acid from individuals exhibiting signs and/or symptoms of gastrointestinal infection aids in the diagnosis of gastrointestinal infection when used in conjunction with clinical evaluation and other laboratory findings.
Recent MDR events
256 adverse event reports on file
- MAXJul 28, 2026MalfunctionGeneohm Sciences Canada, Inc. (bd Diagnostics)3007420875-2026-00161
- BD MAX¿ EXT Enteric Bacterial PanelJul 27, 2026MalfunctionGeneohm Sciences Canada, Inc. (bd Diagnostics)3007420875-2026-00160
- BD MAX¿ EXT ENTERIC BACTERIAL PANELJul 21, 2026MalfunctionGeneohm Sciences Canada, Inc. (bd Diagnostics)3007420875-2026-00144
- BD MAX¿ EXT ENTERIC BACTERIAL PANELJul 21, 2026MalfunctionGeneohm Sciences Canada, Inc. (bd Diagnostics)3007420875-2026-00146
- BD MAX¿ EXT ENTERIC BACTERIAL PANELJul 21, 2026MalfunctionGeneohm Sciences Canada, Inc. (bd Diagnostics)3007420875-2026-00145
- BD MAX¿ EXT ENTERIC BACTERIAL PANELJul 21, 2026MalfunctionGeneohm Sciences Canada, Inc. (bd Diagnostics)3007420875-2026-00147
- BD MAX¿ EXT ENTERIC BACTERIAL PANELJul 21, 2026MalfunctionGeneohm Sciences Canada, Inc. (bd Diagnostics)3007420875-2026-00148
- BD MAX¿ EXT ENTERIC BACTERIAL PANELJul 21, 2026MalfunctionGeneohm Sciences Canada, Inc. (bd Diagnostics)3007420875-2026-00153
- BD MAX¿ EXT ENTERIC BACTERIAL PANELJul 21, 2026MalfunctionGeneohm Sciences Canada, Inc. (bd Diagnostics)3007420875-2026-00152
- BD MAX¿ EXT ENTERIC BACTERIAL PANELJul 21, 2026MalfunctionGeneohm Sciences Canada, Inc. (bd Diagnostics)3007420875-2026-00150
Event type breakdown
Most-reported manufacturers
Recalls
24 recall events for this product code
- GET TESTED INTERNATIONAL ABOpen, ClassifiedDec 1, 2025
GI Microbiome Profile Small
Distribution without premarket approval/clearance.
Z-0763-2026 · View FDA record ↗ - GET TESTED INTERNATIONAL ABOpen, ClassifiedDec 1, 2025
GI Microbiome Profile XL
Distribution without premarket approval/clearance.
Z-0764-2026 · View FDA record ↗ - GET TESTED INTERNATIONAL ABOpen, ClassifiedDec 1, 2025
Mycotoxin Panel Test
Distribution without premarket approval/clearance.
Z-0765-2026 · View FDA record ↗ - GET TESTED INTERNATIONAL ABOpen, ClassifiedDec 1, 2025
Intestinal Worms Test
Distribution without premarket approval/clearance.
Z-0785-2026 · View FDA record ↗ - GET TESTED INTERNATIONAL ABOpen, ClassifiedDec 1, 2025
Parasite Test
Distribution without premarket approval/clearance.
Z-0793-2026 · View FDA record ↗ - BioFire Diagnostics, LLCOpen, ClassifiedSep 30, 2024
FILMARRAY Gastrointestinal (GI) Panel (Part No.: RFIT-ASY-0104 & RFIT-ASY-0116) Pouch Module Software
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 · View FDA record ↗ - BioFire Diagnostics, LLCOpen, ClassifiedAug 6, 2024
BIOFIRE FILMARRAY Gastrointestinal (GI) Panel REF RFIT-ASY-0116
Due to increase of false positive Vibrio/Vibrio Cholerae results when using a certain transport medium.
Z-2514-2024 · View FDA record ↗ - BioFire Diagnostics, LLCOpen, ClassifiedFeb 15, 2024
FilmArray Gastrointestinal (GI) Panel
Due to potential signals of increased false positive Norovirus results when using the gastrointestinal (GI) panel.
Z-1140-2024 · View FDA record ↗ - BioFire Diagnostics, LLCOpen, ClassifiedJan 10, 2024
BIOFIRE FILMARRAY Gastrointestinal (GI) Panel is a qualitative multiplexed nucleic acid-based in vitro diagnostic test intended for use with BIOFIRE FILMARRAY S
A manufacturing event may contribute to elevated rates of false negative results while using gastrointestinal panel and respiratory panel, which could lead to inappropriate antibiotic treatment, no treatment, delay of treatment, and may provide false assurance to someone with a true infection, delayed identification of an outbreak, and may result in additional transmission.
Z-0703-2024 · View FDA record ↗ - Luminex CorporationOpen, ClassifiedJun 28, 2023
Verigene Enteric Pathogens Nucleic Acid Test (EP), REF 30-002-023
It is possible that in rare instances the VERIGENE CDF Nucleic Acid Test Kit (Part No. 20-005-022) and the VERIGENE Enteric Pathogens Nucleic Acid Test Kit (Part No. 20-005-023) could provide a false-negative result due to hydrophobic characteristics in specific FLOQSwab lots.
Z-2023-2023 · View FDA record ↗
Registered firms
48 firms currently registered for this product code
Acro Biotech Inc.
Montclair, CA, US
Cepheid Ab
SOLNA Stockholm, SE
Hologic, Inc.
SAN DIEGO, CA, US
Luminex Corporation
Northbrook, IL, US
Luminex Molecular Diagnostics, Inc.
TORONTO Ontario, CA
Applied Biocode, Inc.
Santa Fe Springs, CA, US
Biofire Diagnostics, Llc
Salt Lake City, UT, US
Becton, Dickinson & Co.
SPARKS, MD, US
Luminex Corporation
AUSTIN, TX, US
Geneohm Sciences Canada, Ulc.
Quebec, CA
Cepheid
Sunnyvale, CA, US
Biogx
Birmingham, AL, US
Cepheid
Lodi, CA, US
510(k) clearances
38 clearances for this product code
- Luminex CorporationMay 19, 2026
K253722 · LIAISON PLEX Gastrointestinal Flex Assay
- QIAGEN GmbHMar 9, 2026
K254032 · QIAstat-Dx Gastrointestinal Panel 2; QIAstat-Dx GI Panel 2 Mini B&V; QIAstat-Dx GI Panel 2 Mini B
- CepheidJan 16, 2026
K251721 · Xpert GI Panel
- QIAGEN GmbHOct 22, 2025
K252329 · QIAstat-Dx Gastrointestinal Panel 2; QIAstat-Dx GI Panel 2 Mini B&V; QIAstat-Dx GI Panel 2 Mini B
- HologicSep 25, 2025
K251868 · Panther Fusion GI Bacterial Assay
- Hologic, Inc.Sep 25, 2025
K251993 · Panther Fusion GI Expanded Bacterial Assay
- QIAGEN GmbHFeb 28, 2025
K250324 · QIAstat-Dx GI Panel 2 Mini B
- Biofire Diagnostics, LLCJan 16, 2025
K243885 · BIOFIRE FILMARRAY Gastrointestinal (GI) Panel Mid