Z-2952-2018Class II

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

Name: Z-2952-2018 Verigene Enteric Pathogens Nucleic Acid Test (EP) for detecting and identification of pathogenic enteric...
Creator: Luminex Corporation
Published: 2018-05-08
License: https://open.fda.gov/license/

Luminex Corporation / initiated 2018-05-08 / Terminated

FDA source

Luminex Corporation began a recall of Verigene Enteric Pathogens Nucleic Acid Test (EP) for detecting and identification of pathogenic enteric bacteria, viruses, and genetic virulence markers from... on 2018-05-08. FDA classified it as Class II and gives the reason as "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)". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-2952-2018
Classification: Class II
Status: Terminated
Initiated: 2018-05-08
Posted: 2018-10-11
Terminated: 2020-06-29
Recalling firm: Luminex Corporation
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.
Product code: PCH Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-Based Assay System
Reason for recall: 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).
FDA root cause: Under Investigation by firm
Action: The firm notified customers on or about 05/08/2018 via a letter entitled "URGENT: MEDICAL DEVICE RECALL". The Luminex informed the customer reason why they are receiving a recall notice---elevated false positive Yersinia enterocolitica (Yersinia) results when using the EP Nucleic Acid Test Cartridges component (20-006-023) from the Verigene EP Nucleic Acid Test Kit (20-005-023). The letter described the intended use of the test kit and the distribution dates. The letter provided instructions for destroying the product if found in the inventory by a customer at a customer site. Luminex advised the customer to complete and return an enclosed Acknowledgment and Receipt form whether a customer had a recalled product on site or not. Luminex Technical Support are available assist in completing this form. Luminex Customer Experience Team contact information is as follows: 1-877-785-2323 (U.S. and Canada) (24 hours/7days) +1-512-381-4397 (Outside U.S. and Canada) (24 hours/7days) [email protected]
Quantity in commerce: 790 Cartridge Carriers containing 3160 Cartridges
Distribution: Domestic Distribution: Arizona, Colorado, Connecticut, Florida, Georgia, Illinois, Indiana, Kansas, Michigan, Minnesota, Missouri, New Hampshire, Tennessee, Texas, Utah, West Virginia, Wisconsin.
Product codes and lots: Catalog number 20-005-023; Cartridge Catalog number 20-006-023; Lot 032718023A; UDI 00857573006041

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2952-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2952-2018	Class II	Terminated	Voluntary: Firm initiated	2018-09-05	2018-08-30

Product code PCH

K142033Class IIVerigene Enteric Pathogen Nucleic Acid Test (Ep)Nanospere,Inc. / cleared 2014-10-10

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)