Diagnostics makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in United StatesLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field., part of DiaSorinLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 3 spellings of its name, each linked to the record.
As of Nov 15, 2026, FDA's public records list Luminex Corporation with 39 device recalls and 18 510(k) clearances. The most recent is a 510(k) clearance dated May 19, 2026: LIAISON PLEX Gastrointestinal Flex Assay.
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| May 19, 2026 | LIAISON PLEX Gastrointestinal Flex AssayK253722 · PCH | 510(k) clearances |
| Jun 6, 2025 | LIAISON PLEX Gram-Positive Blood Culture AssayK243490 · PAM | 510(k) clearances |
| Apr 18, 2025 | LIAISON PLEX Gram-Negative Blood Culture AssayK243013 · PEN | 510(k) clearances |
| Apr 16, 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 Class II · It was determined that the consumable issue may result in No Call - INT CTL 1 and/or False Negative results on a small p | Device recalls |
| Jun 20, 2024 | Verigene Gram Positive Blood Culture (BC-GP) Nucleic Acid TestClass II · Potential for defective test cartridges which may result in false positive results for the Staphylococcus lugdunensis an | Device recalls |
| Jun 4, 2024 | LIAISON PLEX Yeast Blood Culture AssayK240627 · PEO | 510(k) clearances |
| Mar 1, 2024 | LIAISON PLEX Respiratory Flex AssayK233410 · QOF | 510(k) clearances |
| Nov 7, 2023 | Luminex VERIGENE BC-GP Utility Tray (5-Pack Carrier), Gram-Positive Blood Culture Nucleic Acid Test, REF 20-011-018, a component of the LumiClass II · Potentially defective utility trays in the reagent kits. | Device recalls |
| Jun 5, 2023 | VERIGENE Clostridium difficile Nucleic Acid Test, REF 30-002-022Class II · It is possible that in rare instances the VERIGENE CDF Nucleic Acid Test Kit (Part No. 20-005-022) and the VERIGENE Ente | Device recalls |
| Jun 5, 2023 | Verigene Enteric Pathogens Nucleic Acid Test (EP), REF 30-002-023Class II · It is possible that in rare instances the VERIGENE CDF Nucleic Acid Test Kit (Part No. 20-005-022) and the VERIGENE Ente | Device recalls |
| Sep 14, 2022 | ARIES SARS-CoV-2 Assay, REF: 50-10047Class II · A part defect with the wash 1 syringe of an SARS-CoV-2 assay could lead to incomplete extraction thereby producing an in | Device recalls |
| Jul 14, 2022 | ARIES SARS-CoV-2 AssayClass II · SARS-CoV-2 assay that detects SARS-CoV-2 ORF1ab and N genes may not detect the ORF1ab gene. A positive results if either | Device recalls |
| Jun 17, 2022 | VERIGENE Enteric Pathogens Nucleic Acid Test, Part No. 30-002-23Class II · There is a potential for false negative results using VERIGENE CDF Stool PREP KIT and VERIGENE EP Stool PREP KIT due to | Device recalls |
| Sep 25, 2019 | ARIES MRSA AssayK191742 · NQX | 510(k) clearances |
| Oct 30, 2017 | ARIES Group A Strep Assay, ARIES Group A Strep Assay Protocol File KitK172402 · PGX | 510(k) clearances |
| Jul 21, 2017 | ARIES C. difficile Assay Complete Kit, ARIES C. difficile Assay Protocol File Kit, ARIES C. difficile Assay Kit (24 cassettes), ARIES Stool Resuspension KitK171441 · OZN | 510(k) clearances |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
