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Luminex Corporation FDA Recalls
15 recalls on file across devices, 0 of them Class I and 12 still open. This firm is not matched to a listed company.
Newest first
Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.
| Product |
|---|
| VERIGENE Gram Negative Blood Culture (BC-GN) Nucleic Acid Test, REF 20-006-021; for use with the sample-to-results VERIGClass IIApr 16, 2025It was determined that the consumable issue may result in No |
| Verigene Gram Positive Blood Culture (BC-GP) Nucleic Acid TestClass IIJun 20, 2024Potential for defective test cartridges which may result in |
| Luminex VERIGENE BC-GP Utility Tray (5-Pack Carrier), Gram-Positive Blood Culture Nucleic Acid Test, REF 20-011-018, a cClass IINov 7, 2023Potentially defective utility trays in the reagent kits. |
| VERIGENE Clostridium difficile Nucleic Acid Test, REF 30-002-022Class IIJun 5, 2023It is possible that in rare instances the VERIGENE CDF Nucle |
| Verigene Enteric Pathogens Nucleic Acid Test (EP), REF 30-002-023Class IIJun 5, 2023It is possible that in rare instances the VERIGENE CDF Nucle |
| ARIES SARS-CoV-2 Assay, REF: 50-10047Class IISep 14, 2022A part defect with the wash 1 syringe of an SARS-CoV-2 assay |
| ARIES SARS-CoV-2 AssayClass IIJul 14, 2022SARS-CoV-2 assay that detects SARS-CoV-2 ORF1ab and N genes |
| Verigene CDF Nucleic Acid Test, Part No. 30-002-22Class IIJun 17, 2022There is a potential for false negative results using VERIGE |
| VERIGENE Enteric Pathogens Nucleic Acid Test, Part No. 30-002-23Class IIJun 17, 2022There is a potential for false negative results using VERIGE |
| Verigene Processor SP, Models 10-0000-07/10-0000-07R a component of the Verigene systemClass IIApr 5, 2022Heater within the Verigene System may be outside of establi |
| VERIGENE Nucleic Acid Test Kit-BC-GN Extraction Tray - 9.73 mL, REF 20-009-021Class IIFeb 15, 2022Higher than normal "No Call Internal Control failures" due t |
| ARIES HSV 1&2 Assay, Catalog/REF# 50-10017Class IINov 17, 2021Impacted lot may leak inside the ARIES instrument. Testing c |
| Verigene EP Amplification Reagent Kit TestClass IIAug 3, 2021There is potential for false positive results. |
| ARIES HSV 1&2 Assay, Part Number/REF 50-10017Class IIApr 16, 2021Impacted lot may leak inside the ARIES instrument. |
| VERIGENE Processor SP - Product Usage: intended for processing and identifying nucleic acids utilizing gold nanoparticleClass IIMar 18, 2021Potential for a false-negative result for Vibrio parahaemoly |