Verigene Enteric Pathogens Nucleic Acid Test (EP) for… recallZ-2952-2018 · Luminex Corporation · initiated May 8, 2018

Terminated

Is my device affected?

Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
If yours is listed, follow the instructions from Luminex Corporation or your healthcare provider. The company's action is summarized under what the company is doing.
Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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 category: Under Investigation by firm

What the company is doing

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]

Recall details

Recall number: Z-2952-2018
Status: Terminated
Initiated by the company: May 8, 2018
Recalling firm: Luminex Corporation
Quantity: 790 Cartridge Carriers containing 3160 Cartridges
Product code: PCH
FDA submissions: K142033
Distribution: Domestic Distribution: Arizona, Colorado, Connecticut, Florida, Georgia, Illinois, Indiana, Kansas, Michigan, Minnesota, Missouri, New Hampshire, Tennessee, Texas, Utah, West Virginia, Wisconsin.

Product description

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.

Code information (models, lots, serial numbers)

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

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Enteric Pathogens (EP) Nucleic Acid Test Cartridge 20-006-023
Nanosphere, Inc. · Gastrointestinal Bacterial Panel Multiplex Nucleic Acid-Based Assay System
1 recall0 reports

Sources and updates

Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.

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