Data / Medical devices / United States / Illumina, Inc.

Illumina, Inc.: FDA-registered device maker in San Diego, CA, United States, 3 510(k) clearances and 1 PMA approval

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

Illumina, Inc. is registered with the FDA (registration 3003218906) in San Diego, CA, United States. It lists 6 device types. The FDA files 3 510(k) clearances and 1 PMA approval under its listings, the newest dated August 21, 2024. 9 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3003218906
Address: 5200 Illumina Way, San Diego, CA, United States, 92122
Owner or operator: Illumina, Inc. (10030352)
Roles: Complaint file establishment, Manufacturer, Specification developer
First device listed: January 10, 2014
Registered through: 2026
Brand names listed: DRAGEN for Illumina DNA Prep with Enrichment Dx Application for NextSeq 550Dx, DRAGEN for Illumina DNA Prep with Enrichment Dx Application for NovaSeq 6000Dx, Illumina DRAGEN Server for NextSeq 550Dx, Illumina® DNA Prep with Enrichment Dx with UD Indexes Set A (16 samples), Illumina® DNA Prep with Enrichment Dx with UD Indexes Set A (96 samples), Illumina® DNA Prep with Enrichment Dx with UD Indexes Set B (16 samples), Illumina® DNA Prep with Enrichment Dx with UD Indexes Set B (96 samples), Local Run Manager CF 139 Variant Analysis Module and more

Devices it lists

Device	Product code	Class	Role	Source
Dna And Rna Oncology Controls	SCU	2	Complaint file establishment, Manufacturer	accessdata.fda.gov
High Throughput Dna Sequence Analyzer	PFF	2	Complaint file establishment, Manufacturer, Specification developer	accessdata.fda.gov
Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System	PQP	3	Complaint file establishment, Manufacturer	accessdata.fda.gov
Reagents For Molecular Diagnostic Test Systems	PFT	1	Complaint file establishment, Manufacturer, Specification developer	accessdata.fda.gov
System, Cystic Fibrosis Transmembrane Conductance Regulator Gene, Mutations & Variants Panel Sequencing Detection	PFR	2	Complaint file establishment, Manufacturer	accessdata.fda.gov
System, Cystic Fibrosis Transmembrane Conductance Regulator Gene, Variant Gene Sequence Detection	PFS	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
November 19, 2013	K132750	ILLUMINA MISEQDX CYSTIC FIBROSIS CLINICAL SEQUENCING ASSAY	PFS	Substantially Equivalent	Illumina, Inc.	accessdata.fda.gov
November 19, 2013	K124006	ILLUMINA MISEQDX CYSTIC FIBROSIS 139-VARIANT ASSAY	PFR	Substantially Equivalent	Illumina, Inc.	accessdata.fda.gov
November 19, 2013	DEN130011	ILLUMINA MISEQDX PLATFORM	PFF	Unknown	Illumina, Inc.	accessdata.fda.gov

PMA approvals

Premarket approvals this establishment lists, with the supplements the FDA has decided since.

Approved	PMA number	Device	Product code	Supplements	Latest decision	Source
August 21, 2024	P230011	TruSight Oncology Comprehensive	PQP	8	September 4, 2026	accessdata.fda.gov

Recalls

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

Initiated	Event	Class	Status	Product	Reason	Source
October 28, 2025	97913	Class II	Ongoing	Reagent Kits/ containing flow cells, components of NextSeq 550Dx Instrument: NextSeq 550Dx High Output Reagent Kit v2.5 (75 cycles) IVD, REF: 20028870/NextSeq 550Dx HO FC Cart v2.5, 75 Cycles, REF: 20031098; NextSeq 550D	An instrument intended for sequencing DNA libraries with in vitro diagnostic assays is used with reagent kits including flow cells that have flow cell gaskets that have a quality issue, which may lead to flow cell leaks during runs, which could cause run failures, that may result in: No/insufficient data output, instrument fluidics clogs, toxic substance exp	accessdata.fda.gov
September 17, 2024	99585	Class II	Ongoing	NovaSeq 6000Dx including DRAGEN Server, Catalog Number: 20068232; Illumina DRAGEN Server for NextSeq 550Dx, Catalog Number: 20086130	Retrospectively reported correction for an instrument intended for targeted sequencing of DNA libraries from human genomic DNA used with in vitro diagnostic assays has a server with a security vulnerability.	accessdata.fda.gov
May 8, 2024	99957	Not yet classified	Open, Classified	Nextseq 550Dx Instrument REF: 20005715, FOR IN VITRO DIAGNOSTIC USE	(Retrospectively reported) Cybersecurity vulnerability identified in communication protocol between the customer-provided infrastructure (network storage, servers, or computers) and in vitro diagnostic devices which may result in compromised data transmission.	accessdata.fda.gov
April 5, 2023	92233	Class II	Completed	NextSeq 550Dx Instrument, Catalog # 20005715, contaning Universal Copy Service software	Cybersecurity vulnerability concerning the software used for sequencing instruments.	accessdata.fda.gov
May 3, 2022	90160	Class II	Completed	illumina REF DX-410-1001 Model: MiSeq Dx illumina REF 15036706 Model: MiSeq Dx illumina REF 20014053 Model: MiSeq Dx	cybersecurity vulnerability	accessdata.fda.gov
February 22, 2022	89699	Class II	Completed	Illumina NextSeq 550Dx, REF: 20005715, CE, IVD	There is a potential that the DNA sequence analyzer may short circuit shortly after disconnection and reconnection of circuit board or imaging module due to an insufficient reconnection of the ribbon cable. The short circuit results in the device being inoperable.	accessdata.fda.gov
November 13, 2014	69766	Class II	Terminated	Illumina MiSeqDx Universal Kit 1.0, PN 15039608 The Illumina MiSeqDx Universal Kit 1.0 is a set of reagents and consumables used in the processing of human genomic DNA samples derived from peripheral whole blood, and in	It was discovered a software limitation with MiSeq Reporter software (version 2.2.31) when using the MiSeqDx Universal Kit 1.0 on the MiSeqDx instrument. The software cannot report insertions or deletions at specific genomic locations with respect to the primer.	accessdata.fda.gov
November 6, 2014	69715	Class III	Terminated	Illumina MiSeqDx Cystic Fibrosis Clinical Sequencing Assay in vitro diagnostic system for use on the Illumina MiSeqDx Platform.	Illumina has confirmed a software limitation with MiSeq Reporter software (version 2.2.31) when using the MiSeqDx Cystic Fibrosis Clinical Sequencing Assay on the MiSeqDx instrument.	accessdata.fda.gov
July 28, 2014	68959	Class II	Terminated	Illumina Worklist Manager (IWM) (software v1.0.15), a component of Illumina MiSeqDx Platform. Product Usage: The Illumina MiSeqDx is a sequencing instrument that measures fluorescence signals of labeled nucleotides throu	A software component of the MiSeqDx instrument, called the Illumina Worklist Manager (IWM) v1.0.15, fails to perform as intended	accessdata.fda.gov

Compare with other makers

Updated September 4, 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.