Z-2952-2018 Class II Terminated
FDA device recall Z-2952-2018 was initiated by Luminex Corporation on May 8, 2018 and is designated Class II. 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… The recall status is terminated (terminated Jun 29, 2020). Affected quantity: 790 Cartridge Carriers containing 3160 Cartridges.
Recall Details
- Product Type
- Devices
- Report Date
- Sep 5, 2018
- Initiation Date
- May 8, 2018
- Termination Date
- Jun 29, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 790 Cartridge Carriers containing 3160 Cartridges
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.
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).
Distribution Pattern
Domestic Distribution: Arizona, Colorado, Connecticut, Florida, Georgia, Illinois, Indiana, Kansas, Michigan, Minnesota, Missouri, New Hampshire, Tennessee, Texas, Utah, West Virginia, Wisconsin.
Code Information
Catalog number 20-005-023; Cartridge Catalog number 20-006-023; Lot 032718023A; UDI 00857573006041
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-2952-2018
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026