FDAMay 8, 2018device
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.
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
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).
What to do
FDA enforcement status: Terminated
Brands named
luminex
UPCs
00857573006041
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
- FDAVERIGENE Gram Negative Blood Culture (BC-GN) Nucleic Acid Test, REF 20-006-021; for use with the sample-to-results VERIGENE System; invitro diagnostic test2025-04-16
- FDANxTAG Respiratory Pathogen Panel, REF: I051C04472024-09-05
- FDANxTAG Respiratory Pathogen Panel +SARS-CoV-2, REF: I056C04682024-09-05
- FDAVerigene Gram Positive Blood Culture (BC-GP) Nucleic Acid Test2024-06-20
- FDALuminex VERIGENE BC-GP Utility Tray (5-Pack Carrier), Gram-Positive Blood Culture Nucleic Acid Test, REF 20-011-018, a component of the Luminex VERIGENE BC-GP Utility Kit, REF 20-012-018, containing 20 tests.2023-11-07
- FDAVerigene Enteric Pathogens Nucleic Acid Test (EP), REF 30-002-0232023-06-05
- FDAVERIGENE Clostridium difficile Nucleic Acid Test, REF 30-002-0222023-06-05
- FDAARIES SARS-CoV-2 Assay, REF: 50-100472022-09-14
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