FDA Medical Device Recalls (openFDA)
Luminex Corporation: 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.
- Recall number
- Z-2952-2018
- 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.
- Status
- Terminated
- Initiated
- 2018-05-08
- Posted
- not on file
- Terminated
- 2020-06-29
- 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).
- 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) support@luminexcorp.com
- Quantity
- 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.
- Lot, serial or model codes
- Catalog number 20-005-023; Cartridge Catalog number 20-006-023; Lot 032718023A; UDI 00857573006041
- 510(k) numbers
- ["K142033"]
- PMA numbers
- not on file
- Product code
- PCH
- Firm FEI
- 3002524000
- Firm city
- Austin
- Firm state
- TX
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28