Facility

Illumina, Inc.

7 recall(s) on record — most severe on record: Class II.

Key facts

7recalls · worst Class II

3inspections · worst VAI

—warning letters in our data

Recalls are listed for the parent company: openFDA recall records do not name a facility. How we attribute records

FDA Establishment Identifier (FEI)	3003218906
Establishment type	Complaint File Establishment per 21 CFR 820.198; Manufacture Medical Device
Location	5200 Illumina Way San Diego, CA, US 92122
Registration status	Active · expires 2026
Parent company	Illumina, Inc. (owner-operator 10030352)
Brand names	TruSight Oncology Comprehensive

Activity by year

Recalls (7)
Inspections (3)

Devices registered here (1)

Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System
Product code PQP (opens in a new tab) · Class III · Unknown

Recalls & enforcement

Class IIOngoing2025-10-28
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…
Class IICompleted2023-04-05
Cybersecurity vulnerability concerning the software used for sequencing instruments.
Class IICompleted2022-05-03
cybersecurity vulnerability
Class IICompleted2022-02-22
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.
Class IITerminated2014-11-13
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.
Class IIITerminated2014-11-06
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.
Class IITerminated2014-07-28
A software component of the MiSeqDx instrument, called the Illumina Worklist Manager (IWM) v1.0.15, fails to perform as intended

FDA inspections (3)

NAI2016-12-14
No Action Indicated · Bioresearch Monitoring
VAI2016-11-10
Voluntary Action Indicated · Compliance: Devices
NAI2016-11-10
No Action Indicated · Compliance: Devices; Postmarket Assurance: Devices

Source: U.S. FDA Inspections Dashboard (opens in a new tab) (device inspection classifications, 2016–present). Data as of 2026-10-06. The dashboard profile can take several seconds to load.

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this facility record at FDA → (opens in a new tab)

Cite this record

RegWarden. “Illumina, Inc. (FEI 3003218906) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3003218906-illumina-inc/

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