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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)

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Device	Model / Reference	Registries	Class	Status
MultiCode® Gardnerella vaginalis Primers	3912	FDA UDI	Class I	Active
Magpix®	MAGPIX	FDA UDI	Class II	Active
MultiCode® BK Virus Primers	3908-21	FDA UDI	Class I	Unknown
SYNCT™ Software	CN-SW47	FDA UDI	Class II	Active
LIAISON PLEX® Chassis	CN-0562-01	FDA UDI	Class II	Active
LIAISON PLEX® Module (Refurbished)	CN-0564-01R	FDA UDI	Class II	Active
xMAP® Sheath Concentrate Pack	40-75680	FDA UDI	Class II	Active
MultiCode® BK Virus Primers	3908	FDA UDI	Class I	Active
FLEXMAP 3D® Performance Verification Kit	F3DIVD-PVER-K25	FDA UDI	Class II	Active
MultiCode® Influenza B Primers	3905	FDA UDI	Class I	Unknown
MHV Control Primers 2	3803	FDA UDI	Class I	Active
MHV DNA Amplification Control	3694	FDA UDI	Class I	Active
Enteric Pathogens (EP) Amplification Tray	20-011-023	FDA UDI	Class II	Active
Luminex® 100/200™ Calibration Kit	LX200-CAL-K25	FDA UDI	Class II	Active
ARIES® System	ARIES M12V1	FDA UDI	Class II	Unknown
Gram-Negative Blood Culture (BC-GN) Utility Tray	20-011-021	FDA UDI	Class II	Active
ARIES® Extraction Kit	50-10026	FDA UDI	Class II	Unknown
Clostridium difficile (CDF) Stool Sample Preparation Kit	30-002-022	FDA UDI	Class II	Active
MAGPIX® Performance Verification Kit	MPXIVD-PVER-K25	FDA UDI	Class II	Active
Gram-Positive Blood Culture (BC-GP) Nucleic Acid Test Cartridge	20-006-018	FDA UDI	Class II	Active
Verigene® Processor SP (Refurbished)	10-0000-07R	FDA UDI	Class II	Active
MultiCode® CMV Primers	3906	FDA UDI	Class I	Active
MultiCode® Fusobacterium Primers	3922	FDA UDI	Class I	Unknown
MultiCode® Enterovirus Primers	3903	FDA UDI	Class I	Active
MHV Control Primers 1	3802-21	FDA UDI	Class I	Unknown
Verigene® Reader (Refurbished)	10-0000-02R	FDA UDI	Class II	Active
MultiCode® VZV Primers	3916	FDA UDI	Class I	Active
MultiCode® Bordetella holmseii Primers	3921	FDA UDI	Class I	Unknown
Enteric Pathogens (EP) Extraction Tray	20-009-023	FDA UDI	Class II	Active
MHV DNA Sample Processing Control	3700	FDA UDI	Class I	Active
Enteric Pathogens (EP) Stool Sample Preparation Kit	30-002-023	FDA UDI	Class II	Active
Hypercoagulation Panel (HC) Nucleic Acid Test Cartridge	20-006-001	FDA UDI	Class II	Unknown
Gram-Negative Blood Culture (BC-GN) Extraction Tray	20-009-021	FDA UDI	Class II	Active
ARIES® MRSA Assay	50-10034	FDA UDI	Class II	Unknown
Clostridium difficile (CDF) Amplification Tray	20-011-022	FDA UDI	Class II	Active
MultiCode® HSV Primers	3900	FDA UDI	Class I	Active
Luminex® 100/200™ Performance Verification Kit	LX200-CON-K25	FDA UDI	Class II	Active
MultiCode® Mycoplasma pneumoniae Primers	3927	FDA UDI	Class I	Active
Verigene® Reader	10-0000-02	FDA UDI	Class II	Active
MHV Control Primers 3	3804	FDA UDI	Class I	Active
Luminex® 100/200™	Luminex 100/200	FDA UDI	Class II	Active
MHV RNA Amplification Control	3695-21	FDA UDI	Class I	Unknown
MultiCode® Group A Strep Primers	3923	FDA UDI	Class I	Unknown
Gram-Negative Blood Culture (BC-GN) Nucleic Acid Test Cartridge	20-006-021	FDA UDI	Class II	Active
MultiCode® Chlamydophila pneumoniae Primers	3925	FDA UDI	Class I	Active
xMAP® Sheath Fluid PLUS	40-50035	FDA UDI	Class II	Active
MHV Control Primers 4	3805	FDA UDI	Class I	Active
FLEXMAP 3D® Calibration Kit	F3DIVD-CAL-K25	FDA UDI	Class II	Active
MHV DNA Sample Processing Control	3710	FDA UDI	Class I	Active
Gram-Positive Blood Culture (BC-GP) Utility Tray	20-011-018	FDA UDI	Class II	Active

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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.