Luminex Corporation
30 recalls on record · Latest: Jun 11, 2025
FDA Devices Moderate Jun 11, 2025
VERIGENE Gram Negative Blood Culture (BC-GN) Nucleic Acid Test, REF 20-006-021; for use with the sample-to-results VERIGENE System; invitro diagnosti…
FDA Devices Moderate Aug 14, 2024
Verigene Gram Positive Blood Culture (BC-GP) Nucleic Acid Test
FDA Devices Moderate Jul 5, 2023
VERIGENE Clostridium difficile Nucleic Acid Test, REF 30-002-022
FDA Devices Moderate Nov 2, 2022
ARIES SARS-CoV-2 Assay, REF: 50-10047
FDA Devices Moderate Aug 24, 2022
ARIES SARS-CoV-2 Assay
FDA Devices Moderate Jul 13, 2022
VERIGENE Enteric Pathogens Nucleic Acid Test, Part No. 30-002-23
FDA Devices Moderate Jul 13, 2022
Verigene CDF Nucleic Acid Test, Part No. 30-002-22
FDA Devices Moderate May 25, 2022
Verigene Processor SP, Models 10-0000-07/10-0000-07R a component of the Verigene system
FDA Devices Moderate Apr 20, 2022
Verigene Processor SP, Model Numbers: 10-0000-07 and 10-0000-07-R
FDA Devices Moderate Jan 26, 2022
ARIES HSV 1&2 Assay, Part Number/REF 50-10017
FDA Devices Moderate Sep 22, 2021
Verigene EP Amplification Reagent Kit Test
FDA Devices Moderate Jul 14, 2021
Verigene Respiratory Pathogens Flex Nucleic Acid Test (RP Flex) Model Number: 20-006-024
FDA Devices Moderate Jul 14, 2021
Verigene Gram Negative Blood Culture Nucleic Acid Test (BC-GN) Model Number: 20-006-021
FDA Devices Moderate Jul 14, 2021
Verigene Enteric Pathogens Nucleic Acid Test (EP) Model Number: 20-006-023
FDA Devices Moderate Jul 14, 2021
Verigene Clostridium difficile Nucleic Acid Test Kit (CDF) Model Number: 20-006-022
FDA Devices Moderate Dec 2, 2020
Verigene Processor SP, Model Numbers 10-0000-07 and 10-0000-07R. Used with assay: Luminex, VERIGENE Gram-Positive Blood Culture Nucleic Acid Test,BC…
FDA Devices Moderate Dec 2, 2020
Verigene Processor SP, Model Numbers 10-0000-07 and 10-0000-07R. Used with assay Luminex, VERIGENE Gram-Negative Blood Culture Nucleic Acid Test, BC…
FDA Devices Moderate Oct 14, 2020
VERIGENE Processor SP Model No. 10-0000-07. An in vitro diagnostic device intended for processing and identifying nucleic acids
FDA Devices Moderate Aug 19, 2020
Verigene Processor SP with assay Luminex, VERIGENE Gram-Negative Blood Culture Nucleic Acid Test, BC-GN, IVD - Product Usage: utilizes a single-use d…
FDA Devices Moderate Aug 19, 2020
Verigene Processor SP with assay: Luminex, VERIGENE Gram-Positive Blood Culture Nucleic Acid Test,BC-GP, IVD - Product Usage: utilizes a single-use d…
FDA Devices Moderate Aug 28, 2019
Luminex Aries M1 System Model: Aries M6V1 Aries Software v1.0 For In Vitro Diagnostic Use in clinical laboratories. Scanner Label/Labeling…
FDA Devices Moderate Aug 21, 2019
ARIES HSV 1&2 Assay , REF 50-10017, UDI # 00840487100295
FDA Devices Moderate Aug 21, 2019
ARIES C. difficile Assay , REF 50-10018, UDI # 00840487100059
FDA Devices Moderate Aug 21, 2019
ARIES Flu A/B & RSV Assay , REF 50-10020, UDI # 00840487100158
FDA Devices Moderate Aug 21, 2019
ARIES GBS Assay , REF 50-10021, UDI # 00840487100165
FDA Devices Moderate Aug 21, 2019
ARIES Group A Strep Assay , REF 50-10041, UDI # 00840487101469
FDA Devices Moderate Aug 21, 2019
Aries Bordetella Assay, REF 50-10037, UDI # 00840487101452
FDA Devices Moderate Aug 21, 2019
ARIES Extraction Kit; ARIES System; SYNCT , REF 50-10026, UDI # 00840487100073
FDA Devices Moderate Nov 21, 2018
VERIGENE Blood Culture Gram-Positive Nucleic Acid Kits (packaged as five-pack carriers) Product Usage: In vitro diagnostic test for the simulta…
FDA Devices Moderate Sep 5, 2018