Luminex recalls

Luminex appears in 39 official U.S. recall notices indexed by RecallRadar, most recently on 2025-06-11.

Company names are normalized from agency data (legal suffixes removed), so related firms may appear under separate pages.

• VERIGENE Gram Negative Blood Culture (BC-GN) Nucleic Acid Test, REF 20-006-021
  FDA Device · Class II · 2025-06-11 · Luminex
• Verigene Gram Positive Blood Culture (BC-GP) Nucleic Acid Test
  FDA Device · Class II · 2024-08-14 · Luminex
• Luminex VERIGENE BC-GP Utility Tray (5-Pack Carrier), Gram-Positive Blood Culture Nucleic Acid Test, REF 20-011-018, a component of the Lum…
  FDA Device · Class II · 2023-12-13 · Luminex
• VERIGENE Clostridium difficile Nucleic Acid Test, REF 30-002-022
  FDA Device · Class II · 2023-07-05 · Luminex
• Verigene Enteric Pathogens Nucleic Acid Test (EP), REF 30-002-023
  FDA Device · Class II · 2023-07-05 · Luminex
• ARIES SARS-CoV-2 Assay, REF: 50-10047
  FDA Device · Class II · 2022-11-02 · Luminex
• ARIES SARS-CoV-2 Assay
  FDA Device · Class II · 2022-08-24 · Luminex
• Verigene CDF Nucleic Acid Test, Part No. 30-002-22
  FDA Device · Class II · 2022-07-13 · Luminex
• VERIGENE Enteric Pathogens Nucleic Acid Test, Part No. 30-002-23
  FDA Device · Class II · 2022-07-13 · Luminex
• VERIGENE Nucleic Acid Test Kit-BC-GN Extraction Tray - 9.73 mL, REF 20-009-021
  FDA Device · Class II · 2022-05-25 · Luminex
• Verigene Processor SP, Models 10-0000-07/10-0000-07R a component of the Verigene system
  FDA Device · Class II · 2022-05-25 · Luminex
• Verigene Processor SP, Model Numbers: 10-0000-07 and 10-0000-07-R
  FDA Device · Class II · 2022-04-20 · Luminex
• ARIES HSV 1&2 Assay, Catalog/REF# 50-10017
  FDA Device · Class II · 2022-02-09 · Luminex
• ARIES HSV 1&2 Assay, Part Number/REF 50-10017
  FDA Device · Class II · 2022-01-26 · Luminex
• Verigene EP Amplification Reagent Kit Test
  FDA Device · Class II · 2021-09-22 · Luminex
• Verigene Respiratory Pathogens Flex Nucleic Acid Test (RP Flex) Model Number: 20-006-024
  FDA Device · Class II · 2021-07-14 · Luminex
• Verigene Clostridium difficile Nucleic Acid Test Kit (CDF) Model Number: 20-006-022
  FDA Device · Class II · 2021-07-14 · Luminex
• Verigene Gram Negative Blood Culture Nucleic Acid Test v2 (BC-GNv2) Model Number: 20-006-026
  FDA Device · Class II · 2021-07-14 · Luminex
• Verigene Gram-Positive Blood Culture Nucleic Acid Test (BC-GP) Model Number: 20-006-018
  FDA Device · Class II · 2021-07-14 · Luminex
• Verigene Enteric Pathogens Nucleic Acid Test (EP) Model Number: 20-006-023
  FDA Device · Class II · 2021-07-14 · Luminex
• Verigene Gram Negative Blood Culture Nucleic Acid Test (BC-GN) Model Number: 20-006-021
  FDA Device · Class II · 2021-07-14 · Luminex
• VERIGENE Processor SP - Product Usage: intended for processing and identifying nucleic acids utilizing gold nanoparticle probe technology
  FDA Device · Class II · 2021-05-05 · Luminex
• Verigene Processor SP, Model Numbers 10-0000-07 and 10-0000-07R. Used with assay: Luminex, VERIGENE Gram-Positive Blood Culture Nucleic Aci…
  FDA Device · Class II · 2020-12-02 · Luminex
• Verigene Processor SP, Model Numbers 10-0000-07 and 10-0000-07R. Used with assay Luminex, VERIGENE Gram-Negative Blood Culture Nucleic Acid…
  FDA Device · Class II · 2020-12-02 · Luminex
• VERIGENE Processor SP Model No. 10-0000-07
  FDA Device · Class II · 2020-10-14 · Luminex
• Verigene Processor SP with assay: Luminex, VERIGENE Gram-Positive Blood Culture Nucleic Acid Test,BC-GP, IVD - Product Usage: utilizes a si…
  FDA Device · Class II · 2020-08-19 · Luminex
• Verigene Processor SP with assay Luminex, VERIGENE Gram-Negative Blood Culture Nucleic Acid Test, BC-GN, IVD - Product Usage: utilizes a si…
  FDA Device · Class II · 2020-08-19 · Luminex
• Luminex Aries M1 System Model: Aries M6V1 Aries Software v1.0 For In Vitro Diagnostic Use in clinical laboratories
  FDA Device · Class II · 2019-08-28 · Luminex
• Aries Bordetella Assay, REF 50-10037, UDI # 00840487101452
  FDA Device · Class II · 2019-08-21 · Luminex
• ARIES Group A Strep Assay , REF 50-10041, UDI # 00840487101469
  FDA Device · Class II · 2019-08-21 · Luminex
• ARIES GBS Assay , REF 50-10021, UDI # 00840487100165
  FDA Device · Class II · 2019-08-21 · Luminex
• ARIES Extraction Kit
  FDA Device · Class II · 2019-08-21 · Luminex
• ARIES HSV 1&2 Assay , REF 50-10017, UDI # 00840487100295
  FDA Device · Class II · 2019-08-21 · Luminex
• ARIES C. difficile Assay , REF 50-10018, UDI # 00840487100059
  FDA Device · Class II · 2019-08-21 · Luminex
• ARIES Flu A/B & RSV Assay , REF 50-10020, UDI # 00840487100158
  FDA Device · Class II · 2019-08-21 · Luminex
• Vergene Amplification Tray - 700uL, BC-GP REF 20-011-018 The Verigene(R) Gram-Positive Blood Culture Nucleic Acid Test (BC-GP) performed us…
  FDA Device · Class III · 2019-02-20 · Luminex
• VERIGENE Blood Culture Gram-Positive Nucleic Acid Kits (packaged as five-pack carriers) Product Usage: In vitro diagnostic test for the sim…
  FDA Device · Class II · 2018-11-21 · Luminex
• Verigene Enteric Pathogens Nucleic Acid Test (EP) for detecting and identification of pathogenic enteric bacteria, viruses, and genetic vir…
  FDA Device · Class II · 2018-09-05 · Luminex
• ARIES System and ARIES M1 System
  FDA Device · Class II · 2017-05-24 · Luminex