Luminex Corporation
Medical device manufacturer in Northbrook, IL.
18510(k) clearances
0PMA approvals
40recalls
Device types
- NSU Instrumentation For Clinical Multiplex Test… 3
- OOI Real Time Nucleic Acid Amplification System 3
- PGI Herpes Virus (Vzv, Hsv1, Hsv2), Dna… 1
- OCC Respiratory Virus Panel Nucleic Acid Assay… 1
- NJR Nucleic Acid Amplification Assay System… 1
- OZZ Bordetella Pertussis Dna Assay System 1
- OZN C. Difficile Toxin Gene Amplification Assay 1
- PGX Groups A, C And G Beta-Hemolytic… 1
- NQX System, Nucleic Acid Amplification Test… 1
- QOF Multi-Target Respiratory Specimen Nucleic… 1
- PEO Fungal Organisms, Nucleic Acid-Based Assay 1
- PEN Gram-Negative Bacteria And Associated… 1
- PAM Gram-Positive Bacteria And Their Resistance… 1
- PCH Gastrointestinal Pathogen Panel Multiplex… 1
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K253722 | LIAISON PLEX Gastrointestinal Flex AssayPCH · Traditional | 05/19/2026SE |
| K243490 | LIAISON PLEX Gram-Positive Blood Culture AssayPAM · Traditional | 06/06/2025SE |
| K243013 | LIAISON PLEX Gram-Negative Blood Culture AssayPEN · Traditional | 04/18/2025SE |
| K240627 | LIAISON PLEX Yeast Blood Culture AssayPEO · Traditional | 06/04/2024SE |
| K233410 | LIAISON PLEX Respiratory Flex AssayQOF · Traditional | 03/01/2024SE |
| K191742 | ARIES MRSA AssayNQX · Traditional | 09/25/2019SE |
| K172402 | ARIES Group A Strep Assay, ARIES Group A Strep Assay Protocol File KitPGX · Traditional | 10/30/2017SE |
| K171441 | ARIES C. difficile Assay Complete Kit, ARIES C. difficile Assay Protocol File Kit, ARIES…OZN · Traditional | 07/21/2017SE |
| K163626 | ARIES Bordetella Assay; ARIES Bordetella Assay Protocol File KitOZZ · Traditional | 05/02/2017SE |
| K162772 | ARIES GBS AssayNJR · Traditional | 12/23/2016SE |
| K161220 | ARIES® Flu A/B & RSV AssayOCC · Traditional | 08/02/2016SE |
| K161495 | ARIES MI System, ARIES HSV 1&2 Assay Cassettes-Carton of 24 (IVD), ARIES HSV 1&2 Assay…OOI · Special | 06/30/2016SE |
| K160517 | ARIES SystemOOI · Special | 04/12/2016SE |
| K151917 | ARIES SystemOOI · Traditional | 10/06/2015SE |
| K151906 | ARIES HSV 1&2 Assay Cassettes - Carton of 24 (IVD), ARIES HSV 1&2 Assay Protocol File…PGI · Traditional | 10/06/2015SE |
| K133302 | Flexmap 3DNSU · Traditional | 01/10/2014SE |
| K121399 | Luminex Flexmap 3D Instrument System, Luminex Xponent 4.0 Spi Software, Flexmap 3D IVD…NSU · Traditional | 01/09/2013SE |
| K073506 | Luminex LX 100/200 InstrumentNSU · Traditional | 03/07/2008SE |
Recalls
| Recall | Product | Initiated |
|---|---|---|
| Z-1903-2025 Class II | VERIGENE Gram Negative Blood Culture (BC-GN) Nucleic Acid Test, REF 20-006-021; for use…It was determined that the consumable issue may result in No Call - INT CTL 1 and/or False Negative results… | 04/16/2025Completed |
| Z-2533-2024 Class II | Verigene Gram Positive Blood Culture (BC-GP) Nucleic Acid TestPotential for defective test cartridges which may result in false positive results for the Staphylococcus… | 06/20/2024Open, Classified |
| Z-0500-2024 Class II | Luminex VERIGENE BC-GP Utility Tray (5-Pack Carrier), Gram-Positive Blood Culture…Potentially defective utility trays in the reagent kits. | 11/07/2023Open, Classified |
| Z-2024-2023 Class II | VERIGENE Clostridium difficile Nucleic Acid Test, REF 30-002-022It is possible that in rare instances the VERIGENE CDF Nucleic Acid Test Kit (Part No. 20-005-022) and the… | 06/05/2023Open, Classified |
| Z-2023-2023 Class II | Verigene Enteric Pathogens Nucleic Acid Test (EP), REF 30-002-023It is possible that in rare instances the VERIGENE CDF Nucleic Acid Test Kit (Part No. 20-005-022) and the… | 06/05/2023Open, Classified |
| Z-0134-2023 Class II | ARIES SARS-CoV-2 Assay, REF: 50-10047A part defect with the wash 1 syringe of an SARS-CoV-2 assay could lead to incomplete extraction thereby… | 09/14/2022Open, Classified |
| Z-1524-2022 Class II | ARIES SARS-CoV-2 AssaySARS-CoV-2 assay that detects SARS-CoV-2 ORF1ab and N genes may not detect the ORF1ab gene. A positive… | 07/14/2022Open, Classified |
| Z-1335-2022 Class II | VERIGENE Enteric Pathogens Nucleic Acid Test, Part No. 30-002-23There is a potential for false negative results using VERIGENE CDF Stool PREP KIT and VERIGENE EP Stool PREP… | 06/17/2022Open, Classified |
| Z-1334-2022 Class II | Verigene CDF Nucleic Acid Test, Part No. 30-002-22There is a potential for false negative results using VERIGENE CDF Stool PREP KIT and VERIGENE EP Stool PREP… | 06/17/2022Open, Classified |
| Z-1092-2022 Class II | Verigene Processor SP, Models 10-0000-07/10-0000-07R a component of the Verigene systemHeater within the Verigene System may be outside of established temperature limits for assays which could… | 04/05/2022Open, Classified |
| Z-1109-2022 Class II | VERIGENE Nucleic Acid Test Kit-BC-GN Extraction Tray - 9.73 mL, REF 20-009-021Higher than normal "No Call Internal Control failures" due to a missing reagent within a small subset of the… | 02/15/2022Open, Classified |
| Z-0553-2022 Class II | ARIES HSV 1&2 Assay, Catalog/REF# 50-10017Impacted lot may leak inside the ARIES instrument. Testing confirmed a leak rate of 0.9%. Leaking cassettes… | 11/17/2021Terminated |
| Z-2451-2021 Class II | Verigene EP Amplification Reagent Kit TestThere is potential for false positive results. | 08/03/2021Open, Classified |
| Z-0498-2022 Class II | ARIES HSV 1&2 Assay, Part Number/REF 50-10017Impacted lot may leak inside the ARIES instrument. | 04/16/2021Terminated |
| Z-1488-2021 Class II | VERIGENE Processor SP - Product Usage: intended for processing and identifying nucleic…Potential for a false-negative result for Vibrio parahaemolyticus, Salmonella, and/or Shigella spp when used… | 03/18/2021Open, Classified |
| Z-2011-2021 Class II | Verigene Gram Negative Blood Culture Nucleic Acid Test v2 (BC-GNv2) Model Number:…Potential for a false-negative result. | 10/30/2020Open, Classified |
| Z-2010-2021 Class II | Verigene Clostridium difficile Nucleic Acid Test Kit (CDF) Model Number: 20-006-022Potential for a false-negative result. | 10/30/2020Open, Classified |
| Z-2009-2021 Class II | Verigene Enteric Pathogens Nucleic Acid Test (EP) Model Number: 20-006-023Potential for a false-negative result. | 10/30/2020Open, Classified |
| Z-2008-2021 Class II | Verigene Gram Negative Blood Culture Nucleic Acid Test (BC-GN) Model Number: 20-006-021Potential for a false-negative result. | 10/30/2020Open, Classified |
| Z-2007-2021 Class II | Verigene Gram-Positive Blood Culture Nucleic Acid Test (BC-GP) Model Number: 20-006-018Potential for a false-negative result. | 10/30/2020Open, Classified |
| Z-2006-2021 Class II | Verigene Respiratory Pathogens Flex Nucleic Acid Test (RP Flex) Model Number: 20-006-024Potential for a false-negative result. | 10/30/2020Open, Classified |
| Z-0477-2021 Class II | Verigene Processor SP, Model Numbers 10-0000-07 and 10-0000-07R. Used with assay…Luminex has determined that three (3) separate test fixtures used by field service engineers to service the… | 10/13/2020Terminated |
| Z-0476-2021 Class II | Verigene Processor SP, Model Numbers 10-0000-07 and 10-0000-07R. Used with assay:…Luminex has determined that three (3) separate test fixtures used by field service engineers to service the… | 10/13/2020Terminated |
| Z-2776-2020 Class II | Verigene Processor SP with assay Luminex, VERIGENE Gram-Negative Blood Culture Nucleic…An instrument failure mode that may result in a Blood Culture Gram Positive (BC-GP) or Gram Negative (BC-GN)… | 06/15/2020Terminated |
| Z-2775-2020 Class II | Verigene Processor SP with assay: Luminex, VERIGENE Gram-Positive Blood Culture Nucleic…An instrument failure mode that may result in a Blood Culture Gram Positive (BC-GP) or Gram Negative (BC-GN)… | 06/15/2020Terminated |
| Z-0920-2022 Class II | Verigene Processor SP, Model Numbers: 10-0000-07 and 10-0000-07-RTwo of three complaints were initiated due to the customers repeatedly obtaining No Call results on the… | 04/22/2019Open, Classified |
| Z-2288-2019 Class II | ARIES Extraction Kit; ARIES System; SYNCT , REF 50-10026, UDI # 00840487100073Through internal investigation, it was discovered that a portion of side cassette assemblies (SCAs) back… | 02/20/2019Open, Classified |
| Z-2287-2019 Class II | ARIES C. difficile Assay , REF 50-10018, UDI # 00840487100059Through internal investigation, it was discovered that a portion of side cassette assemblies (SCAs) back… | 02/20/2019Open, Classified |
| Z-2286-2019 Class II | ARIES Group A Strep Assay , REF 50-10041, UDI # 00840487101469Through internal investigation, it was discovered that a portion of side cassette assemblies (SCAs) back… | 02/20/2019Open, Classified |
| Z-2285-2019 Class II | ARIES GBS Assay , REF 50-10021, UDI # 00840487100165Through internal investigation, it was discovered that a portion of side cassette assemblies (SCAs) back… | 02/20/2019Open, Classified |
| Z-2284-2019 Class II | ARIES Flu A/B & RSV Assay , REF 50-10020, UDI # 00840487100158Through internal investigation, it was discovered that a portion of side cassette assemblies (SCAs) back… | 02/20/2019Open, Classified |
| Z-2283-2019 Class II | ARIES HSV 1&2 Assay , REF 50-10017, UDI # 00840487100295Through internal investigation, it was discovered that a portion of side cassette assemblies (SCAs) back… | 02/20/2019Open, Classified |
| Z-2282-2019 Class II | Aries Bordetella Assay, REF 50-10037, UDI # 00840487101452Through internal investigation, it was discovered that a portion of side cassette assemblies (SCAs) back… | 02/20/2019Open, Classified |
| Z-0822-2019 Class III | Vergene Amplification Tray - 700uL, BC-GP REF 20-011-018 The Verigene(R) Gram-Positive…On lot of VERIGENE(R) BC-GP Utility Kits (20-011-018) were labeled with the VERIGENE(R) Amplification Tray… | 12/26/2018Terminated |
| Z-0054-2021 Class II | VERIGENE Processor SP Model No. 10-0000-07. An in vitro diagnostic device intended for…No results/incorrect results due to failure of the hybridization heater. | 12/10/2018Open, Classified |
| Z-0445-2019 Class II | VERIGENE Blood Culture Gram-Positive Nucleic Acid Kits (packaged as five-pack carriers)…Potential to lead to a false negative results. | 09/14/2018Terminated |
| Z-2292-2019 Class II | Luminex Aries M1 System Model: Aries M6V1 Aries Software v1.0 For In Vitro Diagnostic…An incorrect control board and firmware installed in some of the Hand Held Barcode Scanners could result in… | 06/29/2018Terminated |
| Z-2952-2018 Class II | Verigene Enteric Pathogens Nucleic Acid Test (EP) for detecting and identification of…Elevated false positive results Yersinia enterocolitica (Yersinia) from customers using the EP Nucleic Acid… | 05/08/2018Terminated |
| Z-2094-2017 Class II | ARIES System and ARIES M1 SystemThe hand-held barcode scanner that is used as an accessory to enter ARIES cassette and specimen… | 04/19/2017Terminated |
| Z-3112-2011 | xTAG CYP2D6 Kit v3 IVD For use with Luminex 100/200 Instrument Luminex Molecular…Inaccurate test results, due to possible defective primers, which could lead to incorrect dosage on… | 05/24/2011Terminated |