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Luminex Corporation Recalls

28 recalls on record. Search official CPSC, FDA, and USDA datasets for every recall issued for Luminex Corporation.

28Total Recalls
0Critical
123,291Units Affected
Apr 16, 2025Most Recent
All Recalls

Every Luminex Corporation Recall

Sorted by most recent. Click any recall for full details.

28 recalls
High RiskFDA
Luminex Corporation
VERIGENE Gram Negative Blood Culture (BC-GN) Nucleic Acid Test, REF 20-006-021; for use with the sample-to-results VERIGENE System; invit...
Diagnostic Devices·89 affected·Apr 16, 2025
High RiskFDA
Luminex Corporation
Verigene Gram Positive Blood Culture (BC-GP) Nucleic Acid Test
Medical Devices·1,100 affected·Jun 20, 2024
High RiskFDA
Luminex Corporation
VERIGENE Clostridium difficile Nucleic Acid Test, REF 30-002-022
Medical Devices·114 affected·Jun 5, 2023
High RiskFDA
Luminex Corporation
ARIES SARS-CoV-2 Assay, REF: 50-10047
Diagnostic Devices·5,141 affected·Sep 14, 2022
High RiskFDA
Luminex Corporation
ARIES SARS-CoV-2 Assay
Diagnostic Devices·257 affected·Jul 14, 2022
High RiskFDA
Luminex Corporation
VERIGENE Enteric Pathogens Nucleic Acid Test, Part No. 30-002-23
Medical Devices·5,601 affected·Jun 17, 2022
High RiskFDA
Luminex Corporation
Verigene CDF Nucleic Acid Test, Part No. 30-002-22
Medical Devices·296 affected·Jun 17, 2022
High RiskFDA
Luminex Corporation
Verigene Processor SP, Models 10-0000-07/10-0000-07R a component of the Verigene system
Medical Devices·24 affected·Apr 5, 2022
High RiskFDA
Luminex Corporation
Verigene EP Amplification Reagent Kit Test
Diagnostic Devices·4,579 affected·Aug 3, 2021
High RiskFDA
Luminex Corporation
ARIES HSV 1&2 Assay, Part Number/REF 50-10017
Diagnostic Devices·296 affected·Apr 16, 2021
High RiskFDA
Luminex Corporation
Verigene Respiratory Pathogens Flex Nucleic Acid Test (RP Flex) Model Number: 20-006-024
Respiratory Devices·38,990 affected·Oct 30, 2020
High RiskFDA
Luminex Corporation
Verigene Gram Negative Blood Culture Nucleic Acid Test (BC-GN) Model Number: 20-006-021
Medical Devices·17,110 affected·Oct 30, 2020
High RiskFDA
Luminex Corporation
Verigene Enteric Pathogens Nucleic Acid Test (EP) Model Number: 20-006-023
Medical Devices·24,338 affected·Oct 30, 2020
High RiskFDA
Luminex Corporation
Verigene Processor SP, Model Numbers 10-0000-07 and 10-0000-07R. Used with assay: Luminex, VERIGENE Gram-Positive Blood Culture Nucleic ...
Diagnostic Devices·2,838 affected·Oct 13, 2020
High RiskFDA
Luminex Corporation
Verigene Processor SP, Model Numbers 10-0000-07 and 10-0000-07R. Used with assay Luminex, VERIGENE Gram-Negative Blood Culture Nucleic A...
Diagnostic Devices·2,838 affected·Oct 13, 2020
High RiskFDA
Luminex Corporation
Verigene Processor SP with assay Luminex, VERIGENE Gram-Negative Blood Culture Nucleic Acid Test, BC-GN, IVD - Product Usage: utilizes a ...
Diagnostic Devices·3,016 affected·Jun 15, 2020
High RiskFDA
Luminex Corporation
Verigene Processor SP with assay: Luminex, VERIGENE Gram-Positive Blood Culture Nucleic Acid Test,BC-GP, IVD - Product Usage: utilizes a ...
Diagnostic Devices·3,016 affected·Jun 15, 2020
High RiskFDA
Luminex Corporation
Verigene Processor SP, Model Numbers: 10-0000-07 and 10-0000-07-R
Medical Devices·4 affected·Apr 22, 2019
High RiskFDA
Luminex Corporation
ARIES HSV 1&2 Assay , REF 50-10017, UDI # 00840487100295
Diagnostic Devices·0 affected·Feb 20, 2019
High RiskFDA
Luminex Corporation
ARIES C. difficile Assay , REF 50-10018, UDI # 00840487100059
Diagnostic Devices·0 affected·Feb 20, 2019
High RiskFDA
Luminex Corporation
ARIES Flu A/B & RSV Assay , REF 50-10020, UDI # 00840487100158
Diagnostic Devices·0 affected·Feb 20, 2019
High RiskFDA
Luminex Corporation
ARIES GBS Assay , REF 50-10021, UDI # 00840487100165
Diagnostic Devices·0 affected·Feb 20, 2019
High RiskFDA
Luminex Corporation
ARIES Group A Strep Assay , REF 50-10041, UDI # 00840487101469
Diagnostic Devices·0 affected·Feb 20, 2019
High RiskFDA
Luminex Corporation
Aries Bordetella Assay, REF 50-10037, UDI # 00840487101452
Diagnostic Devices·0 affected·Feb 20, 2019
High RiskFDA
Luminex Corporation
VERIGENE Processor SP Model No. 10-0000-07. An in vitro diagnostic device intended for processing and identifying nucleic acids
Diagnostic Devices·1 affected·Dec 10, 2018
High RiskFDA
Luminex Corporation
VERIGENE Blood Culture Gram-Positive Nucleic Acid Kits (packaged as five-pack carriers) Product Usage: In vitro diagnostic test for...
Diagnostic Devices·12,700 affected·Sep 14, 2018
High RiskFDA
Luminex Corporation
Luminex Aries M1 System Model: Aries M6V1 Aries Software v1.0 For In Vitro Diagnostic Use in clinical laboratories. Scanner La...
Diagnostic Devices·153 affected·Jun 29, 2018
High RiskFDA
Luminex Corporation
Verigene Enteric Pathogens Nucleic Acid Test (EP) for detecting and identification of pathogenic enteric bacteria, viruses, and genetic ...
Medical Devices·790 affected·May 8, 2018