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Enteric Pathogens (EP) Amplification Tray

LUMINEX CORPORATION · Model 20-011-023 · UDI-DI 00840487101544

PCH PCI Prescription

510(k) clearances

256

Adverse events (2 deaths)

Recalls

Facilities

Description

The Verigene® Enteric Pathogens Nucleic Acid Test (EP) is a multiplexed, qualitative test for simultaneous detection and identification of common pathogenic enteric bacteria, viruses, and genetic virulence markers from liquid or soft stool preserved in Cary-Blair medium, collected from individuals with signs and symptoms of gastrointestinal infection.

Recalls

Date	Firm	Reason
2025-11-03	GET TESTED INTERNATIONAL AB	Distribution without premarket approval/clearance.
2025-11-03	GET TESTED INTERNATIONAL AB	Distribution without premarket approval/clearance.
2025-11-03	GET TESTED INTERNATIONAL AB	Distribution without premarket approval/clearance.
2025-11-03	GET TESTED INTERNATIONAL AB	Distribution without premarket approval/clearance.
2025-11-03	GET TESTED INTERNATIONAL AB	Distribution without premarket approval/clearance.
2024-05-16	BioFire Diagnostics, LLC	Due to increase of false positive Vibrio/Vibrio Cholerae results when using a certain transport medium.
2024-01-26	BioFire Diagnostics, LLC	Due to potential signals of increased false positive Norovirus results when using the gastrointestinal (GI) panel.
2023-11-27	BioFire Diagnostics, LLC	A manufacturing event may contribute to elevated rates of false negative results while using gastrointestinal panel and respiratory panel, which could lead to inappropriate antibio
2023-06-05	Luminex Corporation	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) co
2023-04-25	BioFire Diagnostics, LLC	The firm has identified an increased risk of obtaining false positive Cryptosporidium results from customers using the BIOFIRE FILMARRAY Gastrointestinal (GI) Panel

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.