Data / Medical devices / United States / Luminex Corporation

Luminex Corporation: FDA-registered device maker in Austin, TX, United States, 7 510(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 1650733) in Austin, TX, United States. It lists 10 device types. The FDA files 7 510(k) clearances under its listings, the newest dated April 12, 2016. 14 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 3, 2026.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

Get makers like this one Watch Luminex Corporation

FDA registration number: 1650733
FEI number: 3002524000
Address: 12212 Technology Blvd, Austin, TX, United States, 78727
Owner or operator: Luminex Corporation (9032042)
Roles: Complaint file establishment, Contract manufacturer, Manufacturer, Remanufacturer
First device listed: April 16, 2008
Registered through: 2026
Brand names listed: FLEXMAP 3D, Gastrointestinal Pathogen Panel (GPP), LIAISON PLEX System, Luminex 100, Luminex 100/200, Luminex 200, MAGPIX, MAGPIX® Drive Fluid PLUS (4PK) and more

Devices it lists

Device	Product code	Class	Role	Source
Bordetella Pertussis Dna Assay System	OZZ	2	Complaint file establishment, Manufacturer, Remanufacturer	accessdata.fda.gov
Clinical Sample Concentrator	JJH	1	Manufacturer	accessdata.fda.gov
Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-Based Assay System	PCH	2	Manufacturer	accessdata.fda.gov
Human Metapneumovirus (Hmpv) Rna Assay System	OEM	2	Complaint file establishment, Manufacturer, Remanufacturer	accessdata.fda.gov
Influenza A And Influenza B Multiplex Nucleic Acid Assay	OZE	2	Complaint file establishment, Manufacturer, Remanufacturer	accessdata.fda.gov
Influenza A Virus Subtype Differentiation Nucleic Acid Assay	OEP	2	Complaint file establishment, Manufacturer, Remanufacturer	accessdata.fda.gov
Instrumentation For Clinical Multiplex Test Systems	NSU	2	Contract manufacturer, Manufacturer	accessdata.fda.gov
Parainfluenza Multiplex Nucleic Acid Assay	OOU	2	Complaint file establishment, Manufacturer, Remanufacturer	accessdata.fda.gov
Real Time Nucleic Acid Amplification System	OOI	2	Complaint file establishment, Manufacturer, Remanufacturer	accessdata.fda.gov
Respiratory Virus Panel Nucleic Acid Assay System	OCC	2	Complaint file establishment, Manufacturer, Remanufacturer	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
April 12, 2016	K160517	ARIES System	OOI	Substantially Equivalent	Luminex Corporation	accessdata.fda.gov
December 17, 2015	K152386	NxTAG Respiratory Pathogen Panel, NxTAG Respiratory Pathogen Panel Files, SYNCT Software	OCC	Substantially Equivalent	Luminex Molecular Diagnostics, Inc.	accessdata.fda.gov
September 4, 2015	K143653	Verigene Respiratory Pathogens Flex Nucleic Acid Test (RP Flex)	OCC	Substantially Equivalent	Nanosphere, Inc.	accessdata.fda.gov
January 10, 2014	K133302	FLEXMAP 3D	NSU	Substantially Equivalent	Luminex Corp.	accessdata.fda.gov
March 21, 2013	K121894	XTAG GASTROINTESTINAL PATHOGEN PANEL(GPP) XTAG DATA ANALYSIS SOFTWARE FOR GPP (TDAS GPP) LUMINEX MAGPIX	PCH	Substantially Equivalent	Luminex Molecular Diagnostics, Inc.	accessdata.fda.gov
January 9, 2013	K121399	LUMINEX FLEXMAP 3D INSTRUMENT SYSTEM, LUMINEX XPONENT 4.0 SPI SOFTWARE, FLEXMAP 3D IVD CALIBRATION KIT, FLEXMAP 3D IVD P	NSU	Substantially Equivalent	Luminex Corp.	accessdata.fda.gov
March 7, 2008	K073506	LUMINEX LX 100/200 INSTRUMENT	NSU	Substantially Equivalent	Luminex Corp.	accessdata.fda.gov

Recalls

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

Initiated	Event	Class	Status	Product	Reason	Source
September 14, 2022	90937	Class II	Ongoing	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.	accessdata.fda.gov
July 14, 2022	90698	Class II	Ongoing	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.	accessdata.fda.gov
April 5, 2022	90023	Class II	Ongoing	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.	accessdata.fda.gov
November 17, 2021	89244	Class II	Terminated	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.	accessdata.fda.gov
April 16, 2021	89303	Class II	Terminated	ARIES HSV 1&2 Assay, Part Number/REF 50-10017	Impacted lot may leak inside the ARIES instrument.	accessdata.fda.gov
June 15, 2020	85872	Class II	Terminated	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	An instrument failure mode that may result in a Blood Culture Gram Positive (BC-GP) or Gram Negative (BC-GN) false negative call.	accessdata.fda.gov
February 20, 2019	83470	Class II	Ongoing	Aries Bordetella Assay, REF 50-10037, UDI # 00840487101452	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.	accessdata.fda.gov
December 26, 2018	81890	Class III	Terminated	Vergene Amplification Tray - 700uL, BC-GP REF 20-011-018 The Verigene(R) Gram-Positive Blood Culture Nucleic Acid Test (BC-GP) performed using the sample-to-result Verigene System is a qualitative, multiplexed in vitro d	On lot of VERIGENE(R) BC-GP Utility Kits (20-011-018) were labeled with the VERIGENE(R) Amplification Tray label.	accessdata.fda.gov
December 10, 2018	86358	Class II	Ongoing	VERIGENE Processor SP Model No. 10-0000-07. An in vitro diagnostic device intended for processing and identifying nucleic acids	No results/incorrect results due to failure of the hybridization heater.	accessdata.fda.gov
September 14, 2018	81220	Class II	Terminated	VERIGENE Blood Culture Gram-Positive Nucleic Acid Kits (packaged as five-pack carriers) Product Usage: In vitro diagnostic test for the simultaneous detection and identification of potentially pathogenic gram-positive ba	Potential to lead to a false negative results.	accessdata.fda.gov
June 29, 2018	81420	Class II	Terminated	Luminex Aries M1 System Model: Aries M6V1 Aries Software v1.0 For In Vitro Diagnostic Use in clinical laboratories. Scanner Label/Labeling: JADAK JDK-2330 REV B 170512-017	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.	accessdata.fda.gov
May 8, 2018	80517	Class II	Terminated	Verigene Enteric Pathogens Nucleic Acid Test (EP) for detecting and identification of pathogenic enteric bacteria, viruses, and genetic virulence markers from liquid or soft stool preserved in Cary-Blair medium, collecte	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).	accessdata.fda.gov
April 19, 2017	77052	Class II	Terminated	ARIES System and ARIES M1 System	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.	accessdata.fda.gov
May 24, 2011	59345	Not yet classified	Terminated	xTAG CYP2D6 Kit v3 IVD For use with Luminex 100/200 Instrument Luminex Molecular Diagnostics, Inc. 439 University Ave. Toronto, Ontario Canada Catalog # I030B0373 The xTAG CYP2D6 Kit v3 is a device used to simultaneously	Inaccurate test results, due to possible defective primers, which could lead to incorrect dosage on manufactured drug assays.	accessdata.fda.gov

Compare with other makers

Updated October 26, 2022. 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.