FDA Device recall Z-2952-2018

Verigene Enteric Pathogens Nucleic Acid Test (EP) for detecting and identification of pathogenic enteric bacteria, viruses, and genetic vir…

FDA Device
Class II
terminated
Published 2018-09-05

On 2018-09-05 the FDA classified a Class II recall of Verigene Enteric Pathogens Nucleic Acid Test (EP) for detecting and identification of pathogenic enteric bacteria, viruses, and genetic vir… by Luminex, citing 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 Aci….

Read the official FDA Device notice

Agency	FDA Device
Recall number	Z-2952-2018
Classification	Class II
Status	terminated
Initiated	2018-05-08
Published	2018-09-05
Last updated	2026-09-13 11:54 UTC
Company	Luminex
Distribution	AZ, CO, CT, FL, GA, IL, IN, KS, MI, MN, MO, NH, TN, TX, UT, WI, WV

Product

Verigene Enteric Pathogens Nucleic Acid Test (EP) for detecting and identification of 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.

Reason

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).

Identifiers

code_info	Catalog number 20-005-023; Cartridge Catalog number 20-006-023; Lot 032718023A; UDI 00857573006041

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2952-2018%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.