Luminex Corporation
Austin, TX, US
Luminex Corporation appears in FDA device records in Austin, TX. FDA records list 34 510(k) clearances between and , no PMA records and 2 registered establishments. As of , FDA records show 52 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
FDA records under these names
1 nameFDA records resolved to Luminex Corporation carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.
- Nanosphere, Inc.510(k), enforcement report, recall
510(k) clearance history
FDA records hold 34 510(k) clearances for Luminex Corporation between 2007 and 2026. The busiest year on record is 2009, with 5. The most recent is 2026, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2007 | 2 |
| 2008 | 1 |
| 2009 | 5 |
| 2011 | 2 |
| 2012 | 4 |
| 2013 | 1 |
| 2014 | 3 |
| 2015 | 3 |
| 2016 | 4 |
| 2017 | 3 |
| 2019 | 1 |
| 2024 | 2 |
| 2025 | 2 |
| 2026 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K253722 | LIAISON PLEX Gastrointestinal Flex Assay | PCH | Substantially Equivalent | |
| K243490 | LIAISON PLEX Gram-Positive Blood Culture Assay | PAM | Substantially Equivalent | |
| K243013 | LIAISON PLEX Gram-Negative Blood Culture Assay | PEN | Substantially Equivalent | |
| K240627 | LIAISON PLEX Yeast Blood Culture Assay | PEO | Substantially Equivalent | |
| K233410 | LIAISON PLEX Respiratory Flex Assay | QOF | Substantially Equivalent | |
| K191742 | ARIES MRSA Assay | NQX | Substantially Equivalent | |
| K172402 | ARIES Group A Strep Assay, ARIES Group A Strep Assay Protocol File Kit | PGX | Substantially Equivalent | |
| 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 | OZN | Substantially Equivalent | |
| K163626 | ARIES Bordetella Assay; ARIES Bordetella Assay Protocol File Kit | OZZ | Substantially Equivalent | |
| K162772 | ARIES GBS Assay | NJR | Substantially Equivalent | |
| K161220 | ARIES® Flu A/B & RSV Assay | OCC | Substantially Equivalent | |
| K161495 | ARIES MI System, ARIES HSV 1&2 Assay Cassettes-Carton of 24 (IVD), ARIES HSV 1&2 Assay Protocol File Kit (IVD) | OOI | Substantially Equivalent | |
| K160517 | ARIES System | OOI | Substantially Equivalent | |
| K151917 | ARIES System | OOI | Substantially Equivalent | |
| 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) | PGI | Substantially Equivalent | |
| K143653 | Verigene Respiratory Pathogens Flex Nucleic Acid Test (RP Flex) | OCC | Substantially Equivalent | |
| K140083 | VERIGENE ENTERIC PATHOGEN NUCLEIC ACID TEST ( EP) | PCH | Substantially Equivalent | |
| K133302 | FLEXMAP 3D | NSU | Substantially Equivalent | |
| K132843 | VERIGENE GRAM NEGATIVE BLOOD CULTURE NUCLEIC ACID TEST (BC-GN) | PEN | Substantially Equivalent | |
| K121399 | LUMINEX FLEXMAP 3D INSTRUMENT SYSTEM, LUMINEX XPONENT 4.0 SPI SOFTWARE, FLEXMAP 3D IVD CALIBRATION KIT, FLEXMAP 3D IVD P | NSU | Substantially Equivalent | |
| K123197 | VERIGENE C. DIFFICILE NUCLEIC ACID TEST (CDF) | OZN | Substantially Equivalent | |
| K120466 | VERIGENE CYP2C19 NUCLEIC ACID TES (2C19) | NTI | Substantially Equivalent | |
| K122514 | VERIGENE GRAM-POSITIVE BLOOD CULTURE (GC-GP) NUCLEIC ACID TEST | PAM | Substantially Equivalent | |
| DEN120014 | VERIGENE GRAM POSITIVE BLOOD CULTURE NUCLEIC ACID TEST (BC-GP) | PAM | Unknown | |
| K112424 | VERIGENE STAPHYLOCOCCUS BLOOD CULTURE NUCLEIC ACID TEST (BC-S) | NQX | Substantially Equivalent | |
| K103209 | VERIGENE RESPIRATORY VIRUS NUCLEIC ACID TEST +(RVNAT+) | OCC | Substantially Equivalent | |
| K093337 | VERIGENE RESPIRATORY VIRUS NUCLEIC ACID TEST ON THE VERIGENE SP SYSTEM | OCC | Substantially Equivalent | |
| K092957 | VERIGENE SYSTEM, VERIGENE RESPIRATORY VIRUS NUCLEIC ACID TEST | OCC | Substantially Equivalent | |
| K092566 | VERIGENE RESPIRATORY VIRUS NUCLEIC ACID TEST ON THE VERIGENE SP SYSTEM (RVNATSP) | OCC | Substantially Equivalent | |
| K083294 | VERIGENE CFTR NUCLEIC ACID TEST AND VERIGENE CFTR POLYT NUCLEIC ACID TEST | NUA | Substantially Equivalent | |
| K083088 | VERIGENE RESPIRATORY VIRUS NUCLEIC ACID TEST | OCC | Substantially Equivalent | |
| K073506 | LUMINEX LX 100/200 INSTRUMENT | NSU | Substantially Equivalent | |
| K070597 | VERIGENE SYSTEM, F2 NUCLEIC ACID TEST, F5 NUCLEIC ACID TEST, AND MTHFR NUCLEIC ACID TEST | NSU | Substantially Equivalent | |
| K070804 | VERIGENE SYSTEM, VERIGENE WARFARIN METABOLISM NUCLEIC ACID TEST | ODW | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 1650733 | 3002524000 | Luminex Corporation | 12212 Technology Blvd, AUSTIN, TX 78727 US | 2026 | |
| 3006028115 | 3006028115 | Luminex Corporation | 4088 Commercial Avenue, Northbrook, IL 60062 US | 2026 | and 8 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- OZZBordetella Pertussis Dna Assay System
- OZNC. Difficile Toxin Gene Amplification Assay
- OZYChlamydophila Pneumoniae Dna Assay System
- JJHClinical Sample Concentrator
- ODWCytochrome P450 2c9 (Cyp450 2c9) Drug Metabolizing Enzyme Genotyping System
- NTIDrug Metabolizing Enzyme Genotyping Systems
- PEOFungal Organisms, Nucleic Acid-Based Assay
- PCIGastrointestinal Bacterial Panel Multiplex Nucleic Acid-Based Assay System
- PCHGastrointestinal Pathogen Panel Multiplex Nucleic Acid-Based Assay System
- PENGram-Negative Bacteria And Associated Resistance Markers
- PAMGram-Positive Bacteria And Their Resistance Markers
- PGXGroups A, C And G Beta-Hemolytic Streptococcus Nucleic Acid Amplification System
- PGIHerpes Virus (Vzv, Hsv1, Hsv2), Dna Detection Assay For Cutaneous And Mucocutaneous Lesion Samples
- OEMHuman Metapneumovirus (Hmpv) Rna Assay System
- OZEInfluenza A And Influenza B Multiplex Nucleic Acid Assay
- OEPInfluenza A Virus Subtype Differentiation Nucleic Acid Assay
- NSUInstrumentation For Clinical Multiplex Test Systems
- QOFMulti-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents
- OZXMycoplasma Pneumoniae Dna Assay System
- OTGNon-Sars Coronavirus Multiplex Nucleic Acid Assay
- NJRNucleic Acid Amplification Assay System, Group B Streptococcus, Direct Specimen Test
- OOUParainfluenza Multiplex Nucleic Acid Assay
- OOIReal Time Nucleic Acid Amplification System
- OCCRespiratory Virus Panel Nucleic Acid Assay System
- NUASystem, Cystic Fibrosis Transmembrane Conductance Regulator, Gene Mutation Detection
- NQXSystem, Nucleic Acid Amplification Test, Dna, Methicillin Resistant Staphylococcus Aureus, Direct Specimen
Recall records
Showing 25 of 52| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| 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 | It was determined that the consumable issue may result in No Call - INT CTL 1 and/or False Negative results on a small portion of the lot of test cartridges. | Class II | Completed | |
| Z-2533-2024 | Verigene Gram Positive Blood Culture (BC-GP) Nucleic Acid Test | Potential for defective test cartridges which may result in false positive results for the Staphylococcus lugdunensis and Enterococcus faecium targets. | Class II | Open, Classified | |
| 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. | Potentially defective utility trays in the reagent kits. | Class II | Open, Classified | |
| Z-2024-2023 | VERIGENE Clostridium difficile Nucleic Acid Test, REF 30-002-022 | It is possible that in rare instances the VERIGENE CDF Nucleic Acid Test Kit (Part No. 20-005-022) and the VERIGENE Enteric Pathogens Nucleic Acid Test Kit (Part No. 20-005-023) could provide a false-negative result due to hydrophobic characteristics in specific FLOQSwab lots. | Class II | Open, Classified | |
| Z-2023-2023 | Verigene Enteric Pathogens Nucleic Acid Test (EP), REF 30-002-023 | It is possible that in rare instances the VERIGENE CDF Nucleic Acid Test Kit (Part No. 20-005-022) and the VERIGENE Enteric Pathogens Nucleic Acid Test Kit (Part No. 20-005-023) could provide a false-negative result due to hydrophobic characteristics in specific FLOQSwab lots. | Class II | Open, Classified | |
| Z-0134-2023 | ARIES SARS-CoV-2 Assay, REF: 50-10047 | A part defect with the wash 1 syringe of an SARS-CoV-2 assay could lead to incomplete extraction thereby producing an invalid or false negative assay result. | Class II | Open, Classified | |
| Z-1524-2022 | ARIES SARS-CoV-2 Assay | SARS-CoV-2 assay that detects SARS-CoV-2 ORF1ab and N genes may not detect the ORF1ab gene. A positive results if either SARS-CoV-2 genes is detected, but If both genes are mistakenly not detected, a false negative result would be generated. | Class II | Open, Classified | |
| Z-1335-2022 | VERIGENE Enteric Pathogens Nucleic Acid Test, Part No. 30-002-23 | There is a potential for false negative results using VERIGENE CDF Stool PREP KIT and VERIGENE EP Stool PREP KIT due to hydrophobic characteristics of the swab. | Class II | Open, Classified | |
| Z-1334-2022 | Verigene CDF Nucleic Acid Test, Part No. 30-002-22 | There is a potential for false negative results using VERIGENE CDF Stool PREP KIT and VERIGENE EP Stool PREP KIT due to hydrophobic characteristics of the swab. | Class II | Open, Classified | |
| Z-1092-2022 | Verigene Processor SP, Models 10-0000-07/10-0000-07R a component of the Verigene system | Heater within the Verigene System may be outside of established temperature limits for assays which could result in false negative results. | Class II | Open, Classified | |
| Z-1109-2022 | VERIGENE Nucleic Acid Test Kit-BC-GN Extraction Tray - 9.73 mL, REF 20-009-021 | Higher than normal "No Call Internal Control failures" due to a missing reagent within a small subset of the extraction tray lot. | Class II | Open, Classified | |
| Z-0553-2022 | ARIES HSV 1&2 Assay, Catalog/REF# 50-10017 | Impacted lot may leak inside the ARIES instrument. Testing confirmed a leak rate of 0.9%. Leaking cassettes could potentially lead to incorrect results or a delay in reporting results due to an Invalid. | Class II | Terminated | |
| Z-2451-2021 | Verigene EP Amplification Reagent Kit Test | There is potential for false positive results. | Class II | Open, Classified | |
| Z-0498-2022 | ARIES HSV 1&2 Assay, Part Number/REF 50-10017 | Impacted lot may leak inside the ARIES instrument. | Class II | Terminated | |
| Z-1488-2021 | VERIGENE Processor SP - Product Usage: intended for processing and identifying nucleic acids utilizing gold nanoparticle probe technology. | Potential for a false-negative result for Vibrio parahaemolyticus, Salmonella, and/or Shigella spp when used with the VERIGENE Enteric Pathogens Nucleic Acid Test Kit. | Class II | Open, Classified | |
| Z-2011-2021 | Verigene Gram Negative Blood Culture Nucleic Acid Test v2 (BC-GNv2) Model Number: 20-006-026 | Potential for a false-negative result. | Class II | Open, Classified | |
| Z-2010-2021 | Verigene Clostridium difficile Nucleic Acid Test Kit (CDF) Model Number: 20-006-022 | Potential for a false-negative result. | Class II | Open, Classified | |
| Z-2009-2021 | Verigene Enteric Pathogens Nucleic Acid Test (EP) Model Number: 20-006-023 | Potential for a false-negative result. | Class II | Open, Classified | |
| Z-2008-2021 | Verigene Gram Negative Blood Culture Nucleic Acid Test (BC-GN) Model Number: 20-006-021 | Potential for a false-negative result. | Class II | Open, Classified | |
| Z-2007-2021 | Verigene Gram-Positive Blood Culture Nucleic Acid Test (BC-GP) Model Number: 20-006-018 | Potential for a false-negative result. | Class II | Open, Classified | |
| Z-2006-2021 | Verigene Respiratory Pathogens Flex Nucleic Acid Test (RP Flex) Model Number: 20-006-024 | Potential for a false-negative result. | Class II | Open, Classified | |
| Z-0477-2021 | 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-GN, IVD - Product Usage: IVD sample processor, which utilizes a single-use disposable test consumable and a self-contained Verigene Test Cartridge for each sample tested. | Luminex has determined that three (3) separate test fixtures used by field service engineers to service the VERIGENE SP Processors were procured from unapproved sources and, in some cases, were manufactured using unvalidated processes. These text fixtures were used to calibrate and verify VERIGENE SP devices. | Class II | Terminated | |
| Z-0476-2021 | 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-GP, IVD - Product Usage: IVD sample processor, which utilizes a single-use disposable test consumable and a self-contained Verigene Test Cartridge for each sample tested. | Luminex has determined that three (3) separate test fixtures used by field service engineers to service the VERIGENE SP Processors were procured from unapproved sources and, in some cases, were manufactured using unvalidated processes. These text fixtures were used to calibrate and verify VERIGENESP devices. | Class II | Terminated | |
| Z-2776-2020 | Verigene Processor SP with assay Luminex, VERIGENE Gram-Negative Blood Culture Nucleic Acid Test, BC-GN, IVD - Product Usage: utilizes a single-use disposable test consumables and a self-contained Verigene Test Cartridge for each sample tested. | An instrument failure mode that may result in a Blood Culture Gram Positive (BC-GP) or Gram Negative (BC-GN) false negative call. | Class II | Terminated | |
| Z-2775-2020 | Verigene Processor SP with assay: Luminex, VERIGENE Gram-Positive Blood Culture Nucleic Acid Test,BC-GP, IVD - Product Usage: utilizes a single-use disposable test consumables and a self-contained Verigene Test Cartridge for each sample tested. | An instrument failure mode that may result in a Blood Culture Gram Positive (BC-GP) or Gram Negative (BC-GN) false negative call. | Class II | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain