The Recall Desk

Manufacturer

Illumina, Inc.

9 recalls in our database name Illumina, Inc. as the manufacturing or recalling firm.

What the numbers show

Total
9
Critical
0
Severe
0
Most recent
2025-12-10

Of the 9 recalls from Illumina, Inc. we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 0 (0%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–9 of 9

  • HighFDA (Devices)·Z-0884-2026·2025-12-10

    DNA sequencing reagent kits recalled over flow cell gasket leaks

    Illumina is recalling 11,916 NextSeq 550Dx reagent kits because flow cell gaskets have a quality issue that may cause leaks during runs, including possible toxic substance exposure to the user.

    Product
    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 550Dx High Output Reagent Kit v2.5 (300 cycles) IVD, REF: 2002
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1976-2023·2023-06-28

    NextSeq 550Dx sequencing instruments recalled for cybersecurity software vulnerability

    Illumina is recalling 1,067 NextSeq 550Dx sequencing instruments due to a cybersecurity vulnerability in the Universal Copy Service software. The affected instruments have been distributed worldwide.

    Product
    NextSeq 550Dx Instrument, Catalog # 20005715, contaning Universal Copy Service software
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1977-2023·2023-06-28

    FDA Recalls MiSeq Dx Instruments for Software Cybersecurity Vulnerability

    Illumina recalls 740 MiSeq Dx sequencing instruments due to a software cybersecurity vulnerability affecting the Universal Copy Service component. No patient harm reported.

    Product
    MiSeq Dx Instrument, Catalog # M70101, containing Universal Copy Service (UCS) software.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1260-2022·2022-06-22

    Illumina NextSeq 550 Genetic Sequencer Cybersecurity Vulnerability Recall

    Illumina is recalling 799 NextSeq 550 Dx genetic sequencers due to a cybersecurity vulnerability in the Local Run Manager software. Affected devices have been distributed worldwide and in the United States.

    Product
    illumina Model NextSeq 550 Dx REF 20005715
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1259-2022·2022-06-22

    Illumina MiSeq Dx Sequencing Instruments Recalled Due to Cybersecurity Vulnerability

    Illumina is recalling approximately 1,014 MiSeq Dx sequencing instruments due to a cybersecurity vulnerability. The devices are distributed worldwide and throughout the United States.

    Product
    illumina REF DX-410-1001 Model: MiSeq Dx illumina REF 15036706 Model: MiSeq Dx illumina REF 20014053 Model: MiSeq Dx
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0854-2022·2022-04-06

    Illumina NextSeq 550Dx DNA Analyzer Recalled for Short Circuit Risk

    Illumina is recalling 674 NextSeq 550Dx DNA sequence analyzers worldwide. A short circuit may occur after reconnecting circuit components, causing the device to become inoperable.

    Product
    Illumina NextSeq 550Dx, REF: 20005715, CE, IVD
    Category
    Medical Device
    Distribution
    31 states
  • ModerateFDA (Devices)·Z-0849-2015·2014-12-31

    Illumina MiSeqDx Universal Kit 1.0 Recalled for Software Limitation

    Illumina Inc is recalling 13 units of the MiSeqDx Universal Kit 1.0 because a software limitation prevents the reporting of specific genomic insertions and deletions.

    Product
    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 the subsequent targeted sequencing of the resulting sampl
    Category
    Medical Device
    Distribution
    5 states
  • LowFDA (Devices)·Z-0850-2015·2014-12-31

    Illumina MiSeqDx Cystic Fibrosis Assay Recalled for Software Limitation

    Illumina is recalling 19 units of the MiSeqDx Cystic Fibrosis Clinical Sequencing Assay due to a confirmed software limitation in version 2.2.31.

    Product
    Illumina MiSeqDx Cystic Fibrosis Clinical Sequencing Assay in vitro diagnostic system for use on the Illumina MiSeqDx Platform.
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-2611-2014·2014-09-17

    Illumina Worklist Manager Software Recalled for Performance Failure

    Illumina Inc is recalling 35 units of Illumina Worklist Manager software v1.0.15 because it fails to perform as intended.

    Product
    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 through the use of instrument specific reagents and flow cells
    Category
    Medical Device
    Distribution
    Distributed nationwide

About this company

Community-sourced company facts from Wikidata, not from any recall agency. This is background on the corporate entity — it says nothing about the recall(s) listed on this page, which come from the agency source notice above.

Illumina

American company that develops systems for the analysis of genetic variation

Country
United States
Founded
1998

Official website

Source: Wikidata (Q2068984), licensed CC0. Wikidata is community-edited and may not reflect the current corporate structure.