Luminex Corporation
Luminex Corporation holds FDA 510(k) medical device clearances, first cleared 2015, most recent 2026, with 39 FDA device recalls on record.
Top product codes for Luminex Corporation
FDA recalls by Luminex Corporation
10 most recent of 39- Z-1903-2025 — VERIGENE Gram Negative Blood Culture (BC-GN) Nucleic Acid Test, REF 20-006-021; for use with the sample-to-results VERIGENE System; invitro diagnostic test
- Z-2533-2024 — Verigene Gram Positive Blood Culture (BC-GP) Nucleic Acid Test
- Z-0500-2024 — Luminex VERIGENE BC-GP Utility Tray (5-Pack Carrier), Gram-Positive Blood Culture Nucleic Acid Test, REF 20-011-018, a component of the Luminex VERIGENE BC-GP Utility Kit, REF 20-012-018, containing 20 tests.
- Z-2024-2023 — VERIGENE Clostridium difficile Nucleic Acid Test, REF 30-002-022
- Z-2023-2023 — Verigene Enteric Pathogens Nucleic Acid Test (EP), REF 30-002-023
- Z-0134-2023 — ARIES SARS-CoV-2 Assay, REF: 50-10047
- Z-1524-2022 — ARIES SARS-CoV-2 Assay
- Z-1334-2022 — Verigene CDF Nucleic Acid Test, Part No. 30-002-22
- Z-1335-2022 — VERIGENE Enteric Pathogens Nucleic Acid Test, Part No. 30-002-23
- Z-1092-2022 — Verigene Processor SP, Models 10-0000-07/10-0000-07R a component of the Verigene system
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by Luminex Corporation
- K253722 — LIAISON PLEX Gastrointestinal Flex Assay
- K243490 — LIAISON PLEX Gram-Positive Blood Culture Assay
- K243013 — LIAISON PLEX Gram-Negative Blood Culture Assay
- K240627 — LIAISON PLEX Yeast Blood Culture Assay
- K233410 — LIAISON PLEX Respiratory Flex Assay
- K191742 — ARIES MRSA Assay
- K172402 — ARIES Group A Strep Assay, ARIES Group A Strep Assay Protocol File Kit
- K171441 — ARIES C. difficile Assay Complete Kit, ARIES C. difficile Assay Protocol File Kit, ARIES C. difficile Assay Kit (24 cassettes), ARIES Stool Resuspension Kit
- K163626 — ARIES Bordetella Assay; ARIES Bordetella Assay Protocol File Kit
- K162772 — ARIES GBS Assay
- K161220 — ARIES® Flu A/B & RSV Assay
- K161495 — ARIES MI System, ARIES HSV 1&2 Assay Cassettes-Carton of 24 (IVD), ARIES HSV 1&2 Assay Protocol File Kit (IVD)
- K160517 — ARIES System
- K151906 — ARIES HSV 1&2 Assay Cassettes - Carton of 24 (IVD), ARIES HSV 1&2 Assay Protocol File Kit (IVD), ARIES HSV 1&2 Assay Cassette (IVD)
- K151917 — ARIES System
Data sourced from openFDA. This site is unofficial and independent of the FDA.