Luminex Corporation
5 federal recalls on file. We monitor every CPSC, FDA, USDA, and NHTSA notice for Luminex Corporation and translate it into plain English — free weekly digest, optional same-day alerts.
- 2025-06-11FDA-DeviceClass IIVERIGENE 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
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.
- 2024-08-14FDA-DeviceClass IIVerigene Gram Positive Blood Culture (BC-GP) Nucleic Acid Test
Potential for defective test cartridges which may result in false positive results for the Staphylococcus lugdunensis and Enterococcus faecium targets.
- 2023-12-13FDA-DeviceClass IILuminex 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.
Potentially defective utility trays in the reagent kits.
- 2023-07-05FDA-DeviceClass IIVERIGENE Clostridium difficile Nucleic Acid Test, REF 30-002-022
It is possible that in rare instances the VERIGENE CDF Nucleic Acid Test Kit (Part No. 20-005-022) and the VERIGENE Enteric Pathogens Nucleic Acid Test Kit (Part No. 20-005-023) could provide a false-negative result due to hydrophobic characteristics in specific FLOQSwab lots.
- 2023-07-05FDA-DeviceClass IIVerigene Enteric Pathogens Nucleic Acid Test (EP), REF 30-002-023
It is possible that in rare instances the VERIGENE CDF Nucleic Acid Test Kit (Part No. 20-005-022) and the VERIGENE Enteric Pathogens Nucleic Acid Test Kit (Part No. 20-005-023) could provide a false-negative result due to hydrophobic characteristics in specific FLOQSwab lots.
Get notified about new Luminex Corporation recalls
Free weekly digest. We email when a new federal recall affects Luminex Corporation or anything else in your household.
Get the Sunday Brief