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Luminex Corporation

Last updated September 17, 2026

About

Diasorin is the global leader in Molecular Diagnostics and Immunodiagnostics market. Discover all Diasorin’s diagnostic solutions.

From the manufacturer's own website. Source

What Luminex Corporation makes

Luminex Corporation manufactures multiplex analysers for laboratory use, including systems like the LIAISON PLEX Chassis and FLEXMAP 3D, which support nucleic acid testing and microarray-based diagnostics. Their product portfolio includes kits for detecting bloodstream pathogens, gastrointestinal pathogens, and respiratory viruses, such as the LIAISON PLEX Gastrointestinal Flex Assay and RP Flex Amplification Tray. The company also supplies reagents for internal controls, viral targets like CMV and BKV, and specialized components like extraction trays and calibration kits for Clostridium difficile and Candida glabrata testing.

These devices are regulated under FDA pathways, including 510(k) clearances and de novo submissions, with classifications spanning Class I and Class II. The products are listed in the FDA’s 510(k) and UDI registries, reflecting their compliance with U.S. medical device regulations. Luminex Corporation is headquartered in the United States.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Information

Country: US
Address: 12212 Technology Blvd, AUSTIN, TX, 78727
Website: int.diasorin.com/en
LinkedIn: it.linkedin.com/company/diasorin
Facebook: facebook.com/diasorin
Email: —
Phone: —
PRRC Contact: —
EUDAMED SRN: —
FDA FEI Number: 3002524000
DUNS Number: —

Catalogue (125)

Page 3 of 3

Device	Model / Reference	Registries	Class	Status
MHV Control Primers 3	3804-21	FDA UDI	Class I	Unknown
MultiCode® Bordetella pertussis Primers	3901	FDA UDI	Class I	Active
MHV DNA Sample Processing Control	3700-22	FDA UDI	Class I	Active
MultiCode® Atopobium vaginae Primers	3918	FDA UDI	Class I	Active
ARIES® M1 System	ARIES M6V1	FDA UDI	Class II	Unknown
LIAISON PLEX® Respiratory Flex Assay Kit	20-005-322	FDA UDI	Class II	Active
MHV DNA Sample Processing Control	3700-21	FDA UDI	Class I	Active
Respiratory Pathogens Flex (RP Flex) Extraction Tray	20-009-024	FDA UDI	Class II	Active
ARIES GBS Assay	K162772	FDA 510(k)	Class I	Active
LIAISON PLEX Gram-Positive Blood Culture Assay	K243490	FDA 510(k)	Class II	Active
Luminex Lx 100/200 Instrument	K073506	FDA 510(k)	Class II	Active
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)	K151906	FDA 510(k)	Class II	Active
ARIES Bordetella Assay; ARIES Bordetella Assay Protocol File Kit	K163626	FDA 510(k)	Class II	Active
Flexmap 3d	K133302	FDA 510(k)	Class II	Active
ARIES System	K151917	FDA 510(k)	Class II	Active
LIAISON PLEX Respiratory Flex Assay	K233410	FDA 510(k)	Class II	Active
ARIES System	K160517	FDA 510(k)	Class II	Active
Luminex Flexmap 3d Instrument System, Luminex Xponent 4.0 Spi Software, Flexmap 3d Ivd Calibration Kit, Flexmap 3d Ivd P	K121399	FDA 510(k)	Class II	Active
ARIES MI System, ARIES HSV 1&2 Assay Cassettes-Carton of 24 (IVD), ARIES HSV 1&2 Assay Protocol File Kit (IVD)	K161495	FDA 510(k)	Class II	Active
ARIES Group A Strep Assay, ARIES Group A Strep Assay Protocol File Kit	K172402	FDA 510(k)	Class II	Active
ARIES C. difficile Assay Complete Kit, ARIES C. difficile Assay Protocol File Kit, ARIES C. difficile Assay Kit (24 cassettes), ARIES Stool Resuspension Kit	K171441	FDA 510(k)	Class II	Active
ARIES® Flu A/B & RSV Assay	K161220	FDA 510(k)	Class II	Active
ARIES MRSA Assay	K191742	FDA 510(k)	Class II	Active
LIAISON PLEX Yeast Blood Culture Assay	K240627	FDA 510(k)	Class II	Active
LIAISON PLEX Gram-Negative Blood Culture Assay	K243013	FDA 510(k)	Class II	Active

Related Companies

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FDA Recalls (40)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Luminex Corporation has 40 FDA recall records initiated between May 24, 2011, and April 16, 2025. The records reflect various statuses, including completed, open, classified, and terminated. Recalled items primarily involve diagnostic test cartridges, instruments, and components, with reasons citing potential false negative or positive results, instrument malfunctions, labeling errors, and defects in calibration tools. Issues include barcode scanner errors, reagent failures, and leaks affecting test accuracy, as well as unapproved or improperly validated field service equipment.

AI-generated summary of the recall records listed below. It describes what the records state and is not an assessment of this manufacturer.

Date	Recall No.	Class	Status	Reason
Apr 16, 2025	Z-1903-2025	—	completed	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.
Jun 20, 2024	Z-2533-2024	—	open, classified	Potential for defective test cartridges which may result in false positive results for the Staphylococcus lugdunensis and Enterococcus faecium targets.
Nov 7, 2023	Z-0500-2024	—	open, classified	Potentially defective utility trays in the reagent kits.
Jun 5, 2023	Z-2023-2023	—	open, classified	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.
Jun 5, 2023	Z-2024-2023	—	open, classified	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.
Sep 14, 2022	Z-0134-2023	—	open, classified	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.
Jul 14, 2022	Z-1524-2022	—	open, classified	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.
Jun 17, 2022	Z-1335-2022	—	open, classified	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.
Jun 17, 2022	Z-1334-2022	—	open, classified	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.
Apr 5, 2022	Z-1092-2022	—	open, classified	Heater within the Verigene System may be outside of established temperature limits for assays which could result in false negative results.
Feb 15, 2022	Z-1109-2022	—	open, classified	Higher than normal "No Call Internal Control failures" due to a missing reagent within a small subset of the extraction tray lot.
Nov 17, 2021	Z-0553-2022	—	terminated	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.
Aug 3, 2021	Z-2451-2021	—	open, classified	There is potential for false positive results.
Apr 16, 2021	Z-0498-2022	—	terminated	Impacted lot may leak inside the ARIES instrument.
Mar 18, 2021	Z-1488-2021	—	open, classified	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.
Oct 30, 2020	Z-2008-2021	—	open, classified	Potential for a false-negative result.
Oct 30, 2020	Z-2009-2021	—	open, classified	Potential for a false-negative result.
Oct 30, 2020	Z-2007-2021	—	open, classified	Potential for a false-negative result.
Oct 30, 2020	Z-2010-2021	—	open, classified	Potential for a false-negative result.
Oct 30, 2020	Z-2011-2021	—	open, classified	Potential for a false-negative result.
Oct 30, 2020	Z-2006-2021	—	open, classified	Potential for a false-negative result.
Oct 13, 2020	Z-0476-2021	—	terminated	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.
Oct 13, 2020	Z-0477-2021	—	terminated	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.
Jun 15, 2020	Z-2775-2020	—	terminated	An instrument failure mode that may result in a Blood Culture Gram Positive (BC-GP) or Gram Negative (BC-GN) false negative call.
Jun 15, 2020	Z-2776-2020	—	terminated	An instrument failure mode that may result in a Blood Culture Gram Positive (BC-GP) or Gram Negative (BC-GN) false negative call.
Apr 22, 2019	Z-0920-2022	—	open, classified	Two of three complaints were initiated due to the customers repeatedly obtaining No Call results on the Processor SPs in question.
Feb 20, 2019	Z-2287-2019	—	open, classified	Through internal investigation, it was discovered that a portion of side cassette assemblies (SCAs) back side seal (BSS) did not meet design specification, resulting in partially sealed SCAs. The impact of a partial seal of the BSS could result in potential decrease of volume for each solution in the SCAs and decreased sensitivity or stability of the assay.
Feb 20, 2019	Z-2282-2019	—	open, classified	Through internal investigation, it was discovered that a portion of side cassette assemblies (SCAs) back side seal (BSS) did not meet design specification, resulting in partially sealed SCAs. The impact of a partial seal of the BSS could result in potential decrease of volume for each solution in the SCAs and decreased sensitivity or stability of the assay.
Feb 20, 2019	Z-2286-2019	—	open, classified	Through internal investigation, it was discovered that a portion of side cassette assemblies (SCAs) back side seal (BSS) did not meet design specification, resulting in partially sealed SCAs. The impact of a partial seal of the BSS could result in potential decrease of volume for each solution in the SCAs and decreased sensitivity or stability of the assay.
Feb 20, 2019	Z-2288-2019	—	open, classified	Through internal investigation, it was discovered that a portion of side cassette assemblies (SCAs) back side seal (BSS) did not meet design specification, resulting in partially sealed SCAs. The impact of a partial seal of the BSS could result in potential decrease of volume for each solution in the SCAs and decreased sensitivity or stability of the assay.
Feb 20, 2019	Z-2283-2019	—	open, classified	Through internal investigation, it was discovered that a portion of side cassette assemblies (SCAs) back side seal (BSS) did not meet design specification, resulting in partially sealed SCAs. The impact of a partial seal of the BSS could result in potential decrease of volume for each solution in the SCAs and decreased sensitivity or stability of the assay.
Feb 20, 2019	Z-2285-2019	—	open, classified	Through internal investigation, it was discovered that a portion of side cassette assemblies (SCAs) back side seal (BSS) did not meet design specification, resulting in partially sealed SCAs. The impact of a partial seal of the BSS could result in potential decrease of volume for each solution in the SCAs and decreased sensitivity or stability of the assay.
Feb 20, 2019	Z-2284-2019	—	open, classified	Through internal investigation, it was discovered that a portion of side cassette assemblies (SCAs) back side seal (BSS) did not meet design specification, resulting in partially sealed SCAs. The impact of a partial seal of the BSS could result in potential decrease of volume for each solution in the SCAs and decreased sensitivity or stability of the assay.
Dec 26, 2018	Z-0822-2019	—	terminated	On lot of VERIGENE(R) BC-GP Utility Kits (20-011-018) were labeled with the VERIGENE(R) Amplification Tray label.
Dec 10, 2018	Z-0054-2021	—	open, classified	No results/incorrect results due to failure of the hybridization heater.
Sep 14, 2018	Z-0445-2019	—	terminated	Potential to lead to a false negative results.
Jun 29, 2018	Z-2292-2019	—	terminated	An incorrect control board and firmware installed in some of the Hand Held Barcode Scanners could result in sample/patient mismatch or duplicate results (from other patients specimens) for a patient order.
May 8, 2018	Z-2952-2018	—	terminated	Elevated false positive results Yersinia enterocolitica (Yersinia) from customers using the EP Nucleic Acid Test Cartridges component (20-006-023) from the Verigene EP Nucleic Acid Test Kit (20-005-023).
Apr 19, 2017	Z-2094-2017	—	terminated	The hand-held barcode scanner that is used as an accessory to enter ARIES cassette and specimen identifications on the ARIES Systems populates patient sample IDs with a previously scanned sample ID when entering orders into an ARIES instrument.
May 24, 2011	Z-3112-2011	—	terminated	Inaccurate test results, due to possible defective primers, which could lead to incorrect dosage on manufactured drug assays.