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.
This recall has been terminated (originally issued May 8, 2018).
- Company
- Luminex Corporation
- Recall Initiated
- May 8, 2018
- Terminated
- June 29, 2020
- Recall Number
- Z-2952-2018
- Quantity
- 790 Cartridge Carriers containing 3160 Cartridges
- Firm Location
- Austin, TX
- Official Source
- View on FDA website ↗
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
Domestic Distribution: Arizona, Colorado, Connecticut, Florida, Georgia, Illinois, Indiana, Kansas, Michigan, Minnesota, Missouri, New Hampshire, Tennessee, Texas, Utah, West Virginia, Wisconsin.
Lot / Code Info
Catalog number 20-005-023; Cartridge Catalog number 20-006-023; Lot 032718023A; UDI 00857573006041
Root Cause
Under Investigation by firm
Action Taken
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