Brand
Luminex Corporation
2 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.
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