Luminex Corporation
FDA Regulatory Profile
Luminex Corporation appears in FDA public data with 39 recalls, 15 510(k) clearances, 10 FDA inspections, and 3 compliance actions on record. Its most recent recall (Z-1903-2025, Class II) was initiated on April 16, 2025. Its most recent 510(k) clearance was granted on May 19, 2026.
Summary
- Total Recalls
- 39
- 510(k) Clearances
- 15
- Inspections
- 10
- Compliance Actions
- 3
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-1903-2025 | Class II | VERIGENE Gram Negative Blood Culture (BC-GN) Nucleic Acid Test, REF 20-006-021; for use with the sam | April 16, 2025 |
| Z-2533-2024 | Class II | Verigene Gram Positive Blood Culture (BC-GP) Nucleic Acid Test | June 20, 2024 |
| Z-0500-2024 | Class II | Luminex VERIGENE BC-GP Utility Tray (5-Pack Carrier), Gram-Positive Blood Culture Nucleic Acid Test, | November 7, 2023 |
| Z-2023-2023 | Class II | Verigene Enteric Pathogens Nucleic Acid Test (EP), REF 30-002-023 | June 5, 2023 |
| Z-2024-2023 | Class II | VERIGENE Clostridium difficile Nucleic Acid Test, REF 30-002-022 | June 5, 2023 |
| Z-0134-2023 | Class II | ARIES SARS-CoV-2 Assay, REF: 50-10047 | September 14, 2022 |
| Z-1524-2022 | Class II | ARIES SARS-CoV-2 Assay | July 14, 2022 |
| Z-1335-2022 | Class II | VERIGENE Enteric Pathogens Nucleic Acid Test, Part No. 30-002-23 | June 17, 2022 |
| Z-1334-2022 | Class II | Verigene CDF Nucleic Acid Test, Part No. 30-002-22 | June 17, 2022 |
| Z-1092-2022 | Class II | Verigene Processor SP, Models 10-0000-07/10-0000-07R a component of the Verigene system | April 5, 2022 |
| Z-1109-2022 | Class II | VERIGENE Nucleic Acid Test Kit-BC-GN Extraction Tray - 9.73 mL, REF 20-009-021 | February 15, 2022 |
| Z-0553-2022 | Class II | ARIES HSV 1&2 Assay, Catalog/REF# 50-10017 | November 17, 2021 |
| Z-2451-2021 | Class II | Verigene EP Amplification Reagent Kit Test | August 3, 2021 |
| Z-0498-2022 | Class II | ARIES HSV 1&2 Assay, Part Number/REF 50-10017 | April 16, 2021 |
| Z-1488-2021 | Class II | VERIGENE Processor SP - Product Usage: intended for processing and identifying nucleic acids utilizi | March 18, 2021 |
| Z-2009-2021 | Class II | Verigene Enteric Pathogens Nucleic Acid Test (EP) Model Number: 20-006-023 | October 30, 2020 |
| Z-2011-2021 | Class II | Verigene Gram Negative Blood Culture Nucleic Acid Test v2 (BC-GNv2) Model Number: 20-006-026 | October 30, 2020 |
| Z-2007-2021 | Class II | Verigene Gram-Positive Blood Culture Nucleic Acid Test (BC-GP) Model Number: 20-006-018 | October 30, 2020 |
| Z-2008-2021 | Class II | Verigene Gram Negative Blood Culture Nucleic Acid Test (BC-GN) Model Number: 20-006-021 | October 30, 2020 |
| Z-2006-2021 | Class II | Verigene Respiratory Pathogens Flex Nucleic Acid Test (RP Flex) Model Number: 20-006-024 | October 30, 2020 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K253722 | LIAISON PLEX Gastrointestinal Flex Assay | May 19, 2026 |
| K243490 | LIAISON PLEX Gram-Positive Blood Culture Assay | June 6, 2025 |
| K243013 | LIAISON PLEX Gram-Negative Blood Culture Assay | April 18, 2025 |
| K240627 | LIAISON PLEX Yeast Blood Culture Assay | June 4, 2024 |
| K233410 | LIAISON PLEX Respiratory Flex Assay | March 1, 2024 |
| K191742 | ARIES MRSA Assay | September 25, 2019 |
| K172402 | ARIES Group A Strep Assay, ARIES Group A Strep Assay Protocol File Kit | October 30, 2017 |
| K171441 | ARIES C. difficile Assay Complete Kit, ARIES C. difficile Assay Protocol File Kit, ARIES C. difficil | July 21, 2017 |
| K163626 | ARIES Bordetella Assay; ARIES Bordetella Assay Protocol File Kit | May 2, 2017 |
| K162772 | ARIES GBS Assay | December 23, 2016 |
| K161220 | ARIES® Flu A/B & RSV Assay | August 2, 2016 |
| K161495 | ARIES MI System, ARIES HSV 1&2 Assay Cassettes-Carton of 24 (IVD), ARIES HSV 1&2 Assay Protocol File | June 30, 2016 |
| K160517 | ARIES System | April 12, 2016 |
| K151917 | ARIES System | October 6, 2015 |
| K151906 | ARIES HSV 1&2 Assay Cassettes - Carton of 24 (IVD), ARIES HSV 1&2 Assay Protocol File Kit (IVD), ARI | October 6, 2015 |