Recall Z-2952-2018 ยท PCH Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-Based Assay System
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.
| Date | May 8, 2018 |
| Status | Terminated |
| 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. Lumine |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K142033 | VERIGENE ENTERIC PATHOGEN NUCLEIC ACID TEST (EP) Nanospere,Inc., Oct 10, 2014 |