FDAJuly 14, 2022device
ARIES SARS-CoV-2 Assay
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
SARS-CoV-2 assay that detects SARS-CoV-2 ORF1ab and N genes may not detect the ORF1ab gene. A positive results if either SARS-CoV-2 genes is detected, but If both genes are mistakenly not detected, a false negative result would be generated.
What to do
FDA enforcement status: Ongoing
Brands named
luminex
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
Own something like this?
AllClear screens your whole list against every CPSC, FDA, USDA and NHTSA recall — and tells you the day a new one names something you own.
Start free — 200 items, no card →