Data / Medical devices / United States / Luminex Corporation

Luminex Corporation: FDA-registered device maker in Northbrook, IL, United States, 10 510(k) clearances

Name: Luminex Corporation FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Luminex Corporation is registered with the FDA (registration 3006028115) in Northbrook, IL, United States. It lists 18 device types. The FDA files 10 510(k) clearances under its listings, the newest dated May 19, 2026. 18 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3006028115
Address: 4088 Commercial Avenue, Northbrook, IL, United States, 60062
Owner or operator: Luminex Corporation (9032042)
Roles: Complaint file establishment, Manufacturer
First device listed: August 16, 2016
Registered through: 2026
Brand names listed: LIAISON PLEX Gastrointestinal Flex Assay, LIAISON PLEX Gram-Negative Blood Culture Assay, LIAISON PLEX Respiratory Flex Assay, LIAISON PLEX Yeast Blood Culture Assay, LIAISON PLEX® Gram-Positive Blood Culture Assay, Verigene CDF Nucleic Acid Test, Verigene Enteric Pathogens Nucleic Acid Test (EP); Verigene EP, Verigene Gram Negative Blood Culture Nucleic Acid Test (BC-GN) and more

Devices it lists

Device	Product code	Class	Role	Source
Bordetella Pertussis Dna Assay System	OZZ	2	Complaint file establishment, Manufacturer	accessdata.fda.gov
C. Difficile Toxin Gene Amplification Assay	OZN	2	Manufacturer	accessdata.fda.gov
Chlamydophila Pneumoniae Dna Assay System	OZY	2	Manufacturer	accessdata.fda.gov
Fungal Organisms, Nucleic Acid-Based Assay	PEO	2	Manufacturer	accessdata.fda.gov
Gastrointestinal Bacterial Panel Multiplex Nucleic Acid-Based Assay System	PCI	2	Manufacturer	accessdata.fda.gov
Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-Based Assay System	PCH	2	Manufacturer	accessdata.fda.gov
Gram-Negative Bacteria And Associated Resistance Markers	PEN	2	Manufacturer	accessdata.fda.gov
Gram-Positive Bacteria And Their Resistance Markers	PAM	2	Manufacturer	accessdata.fda.gov
Human Metapneumovirus (Hmpv) Rna Assay System	OEM	2	Complaint file establishment, Manufacturer	accessdata.fda.gov
Influenza A And Influenza B Multiplex Nucleic Acid Assay	OZE	2	Complaint file establishment, Manufacturer	accessdata.fda.gov
Influenza A Virus Subtype Differentiation Nucleic Acid Assay	OEP	2	Complaint file establishment, Manufacturer	accessdata.fda.gov
Instrumentation For Clinical Multiplex Test Systems	NSU	2	Manufacturer	accessdata.fda.gov
Multi-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents	QOF	2	Manufacturer	accessdata.fda.gov
Mycoplasma Pneumoniae Dna Assay System	OZX	2	Manufacturer	accessdata.fda.gov
Non-Sars Coronavirus Multiplex Nucleic Acid Assay	OTG	2	Manufacturer	accessdata.fda.gov
Parainfluenza Multiplex Nucleic Acid Assay	OOU	2	Complaint file establishment, Manufacturer	accessdata.fda.gov
Real Time Nucleic Acid Amplification System	OOI	2	Complaint file establishment, Manufacturer	accessdata.fda.gov
Respiratory Virus Panel Nucleic Acid Assay System	OCC	2	Complaint file establishment, Manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
May 19, 2026	K253722	LIAISON PLEX Gastrointestinal Flex Assay	PCH	Substantially Equivalent	Luminex Corporation	accessdata.fda.gov
June 6, 2025	K243490	LIAISON PLEX Gram-Positive Blood Culture Assay	PAM	Substantially Equivalent	Luminex Corporation	accessdata.fda.gov
April 18, 2025	K243013	LIAISON PLEX Gram-Negative Blood Culture Assay	PEN	Substantially Equivalent	Luminex Corporation	accessdata.fda.gov
June 4, 2024	K240627	LIAISON PLEX Yeast Blood Culture Assay	PEO	Substantially Equivalent	Luminex Corporation	accessdata.fda.gov
March 1, 2024	K233410	LIAISON PLEX Respiratory Flex Assay	QOF	Substantially Equivalent	Luminex Corporation	accessdata.fda.gov
September 4, 2015	K143653	Verigene Respiratory Pathogens Flex Nucleic Acid Test (RP Flex)	OCC	Substantially Equivalent	Nanosphere, Inc.	accessdata.fda.gov
June 20, 2014	K140083	VERIGENE ENTERIC PATHOGEN NUCLEIC ACID TEST ( EP)	PCH	Substantially Equivalent	Nanosphere, Inc.	accessdata.fda.gov
January 8, 2014	K132843	VERIGENE GRAM NEGATIVE BLOOD CULTURE NUCLEIC ACID TEST (BC-GN)	PEN	Substantially Equivalent	Nanosphere, Inc.	accessdata.fda.gov
December 5, 2012	K123197	VERIGENE C. DIFFICILE NUCLEIC ACID TEST (CDF)	OZN	Substantially Equivalent	Nanosphere, Inc.	accessdata.fda.gov
September 19, 2012	K122514	VERIGENE GRAM-POSITIVE BLOOD CULTURE (GC-GP) NUCLEIC ACID TEST	PAM	Substantially Equivalent	Nanosphere, Inc.	accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

Initiated	Event	Class	Status	Product	Reason	Source
April 16, 2025	96701	Class II	Completed	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.	accessdata.fda.gov
June 20, 2024	94970	Class II	Ongoing	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.	accessdata.fda.gov
November 7, 2023	93364	Class II	Ongoing	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.	accessdata.fda.gov
June 5, 2023	92451	Class II	Ongoing	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.	accessdata.fda.gov
June 17, 2022	90122	Class II	Ongoing	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.	accessdata.fda.gov
February 15, 2022	90129	Class II	Ongoing	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.	accessdata.fda.gov
August 3, 2021	88423	Class II	Ongoing	Verigene EP Amplification Reagent Kit Test	There is potential for false positive results.	accessdata.fda.gov
March 18, 2021	87591	Class II	Ongoing	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.	accessdata.fda.gov
October 30, 2020	88137	Class II	Ongoing	Verigene Respiratory Pathogens Flex Nucleic Acid Test (RP Flex) Model Number: 20-006-024	Potential for a false-negative result.	accessdata.fda.gov
October 13, 2020	86124	Class II	Terminated	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-	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.	accessdata.fda.gov
April 22, 2019	89051	Class II	Ongoing	Verigene Processor SP, Model Numbers: 10-0000-07 and 10-0000-07-R	Two of three complaints were initiated due to the customers repeatedly obtaining No Call results on the Processor SPs in question.	accessdata.fda.gov
July 9, 2014	68831	Class II	Terminated	Verigene BC-GN Test Kit (Catalog number 20-005-021) includes: 1) 20 Verigene BC-GN Test Cartridges. Each Test Cartridge comes preloaded with all required reaction solutions, including wash solutions, oligonucleotide prob	Nanosphere Inc. has recently determined through four customer complaints that a small number of Verigene Gram-Negative Blood Culture Nucleic Acid Test (BC-GN) Extraction Trays in Lot 042914021B have low levels or are missing Magnetic Microparticles (MMPs) required for DNA Extraction.	accessdata.fda.gov
April 17, 2014	68177	Class II	Terminated	Verigene Gram-Negative Blood Culture Nucleic Acid Test (BC-GN), performed using the sample-to-result Verigene System, is a qualitative multiplexed in vitro diagnostic test for the simultaneous detection and identificatio	Nanosphere has determined that a portion of BC-GN Test Cartridge Lot number 040214021A has an elevated risk for No Call results and False Negative results. The BC-GN Test Cartridge (20-006-021) is distributed as part of the Verigene BC-GN Test Kit (20-005-021), which is labeled as "IVD". Therefore, Nanosphere has initiated a voluntary recall to retrieve the	accessdata.fda.gov
March 18, 2014	68710	Class III	Terminated	Verigene CYP2C19 Nucleic Acid Test (CYP2C19 Test). Each CYP2C19 kit consists of 20 Verigene CYP2C19 Nucleic Acid Test Cartridges and 20 Verigene CYP2C19 Nucleic Acid Extraction Trays (with Tip Holder Assemblies). Clinica	Nanosphere has recieved reports related to an unacceptable increase in initial no-call rate when performing the Verigene CYP2C19 Nucleic Acid Test (2C19), which has been confirmed through internal testing.	accessdata.fda.gov
October 16, 2013	68708	Class III	Terminated	Nanosphere Verigene Each CDF test consists of a Verigene CDF Nucleic Acid Test Kit and a Verigene CDF Amplification Reagent Kit. The Verigene Clostridium difficile Nucleic Acid Test (CDF) is a qualitative multiplexed in	Nanosphere has received report of an increased rate of "No Call - INT CTL 2" results for the Internal Control 2 (INT CTL 2) when negative samples are tested with certain lots of CDF Amplification Trays (20-011-022), which are contained in the CDF Amplification Reagent Kit (20-012-022); specifically for lots 061913022D and 071813022E.	accessdata.fda.gov
October 10, 2013	69034	Class II	Terminated	The Verigene Gram Negative Blood Culture Nucleic Acid Test (BC-GN), performed using the sample-to-result Verigene System, is a qualitative multiplexed in vitro diagnostic test for the simultaneous detection and identific	Nanosphere has received several reports relating to an increased rate of Processing Errors during procedures performed on the Processor SP caused by Tips in Tip Holder Assemblies for the following products and lots of Extraction Trays.	accessdata.fda.gov
June 17, 2013	68014	Class II	Terminated	Verigene BC-GP Kit (Catalog number 20-005-018); 1) 20 Verigene BC-GP Test Cartridges; are qualitative multiplexed in vitro diagnostic tests for simultaneous detection and identification of selected gram-positive (BC-GP)	There is a specific Extraction Tray lot containing Tips that may slightly increase the occurrence of Process SP Processing Error when used due to the Processor SP experiencing difficulty releasing the Tip to the final location in the Tip Assembly. The difficult releasing the Tip can result in a Processing Error and occasionally the Tip to be dropped into the	accessdata.fda.gov
February 25, 2008	46882	Not yet classified	Terminated	Warfarin Metabolism Nucleic Acid Test Cartridge; Part Number: 20-006-002; an in vitro diagnostic drug metabolizing enzyme genotyping system; Nanosphere, Inc., 4088 Commercial Ave., Northbrook, IL 60062	Aberrant Results: A warfarin 2C9*2 mutant capture signal was found to be high enough to result in an aberrant result (i.e., wild-type called heterozygous).	accessdata.fda.gov

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Updated May 19, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.