Enteric Pathogens (EP) Nucleic Acid Test Cartridge 20-006-023Recalls & reported problems

Nanosphere, Inc. · 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. · Class 2

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

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.

5 other recalls cover devices cleared under the same FDA submission (K140083); 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

May 8, 2018Class IITerminated
Elevated false positive results Yersinia enterocolitica (Yersinia) from customers using the EP Nucleic Acid Test Cartridges component (20-006-023) from the Verigene EP Nucleic Acid Test Kit (20-005-023).
Z-2952-2018 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K140083. One submission often covers many models, so check the product and lot details in each record.

Z-2023-2023 · Jun 5, 2023 · Open, Classified
Verigene Enteric Pathogens Nucleic Acid Test (EP), REF 30-002-023
Z-2451-2021 · Aug 3, 2021 · Open, Classified
Verigene EP Amplification Reagent Kit Test
Z-1488-2021 · Mar 18, 2021 · Open, Classified
VERIGENE Processor SP - Product Usage: intended for processing and identifying nucleic acids utilizing gold nanoparticle probe technology.
Z-2009-2021 · Oct 30, 2020 · Open, Classified
Verigene Enteric Pathogens Nucleic Acid Test (EP) Model Number: 20-006-023
Z-2685-2014 · Oct 10, 2013 · Terminated
The Verigene Enteric Pathogens Nucleic Acid Test (EP) is a multiplexed, qualitative test for simultaneous detection and identification of common pathogenic enteric bacteria and gen

Device details

UDI-DI	`00857573006041`
Brand	Enteric Pathogens (EP) Nucleic Acid Test Cartridge
Model	20-006-023
Company	Nanosphere, Inc.
Product code	PCI · Gastrointestinal Bacterial Panel Multiplex Nucleic Acid-Based Assay System
Class	Class 2
FDA submission	K140083
Implant	No
Rx / OTC	Prescription
Single use	Yes
Sterile	No
MRI safety	Labeling does not contain MRI Safety Information
Status	Not in Commercial Distribution
Record updated	Dec 21, 2020

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

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 microarray method. 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.

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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