FDAApril 16, 2025device
VERIGENE Gram Negative Blood Culture (BC-GN) Nucleic Acid Test, REF 20-006-021; for use with the sample-to-results VERIGENE System; invitro diagnostic test
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
It was determined that the consumable issue may result in No Call - INT CTL 1 and/or False Negative results on a small portion of the lot of test cartridges.
What to do
FDA enforcement status: Completed
Brands named
luminex
UPCs
00840487101599
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
- FDANxTAG Respiratory Pathogen Panel +SARS-CoV-2, REF: I056C04682024-09-05
- FDANxTAG Respiratory Pathogen Panel, REF: I051C04472024-09-05
- 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
- FDAARIES SARS-CoV-2 Assay2022-07-14
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