Illumina, Inc. Recalls

All product recalls associated with Illumina, Inc..

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Recall Summary

Total Recalls

9

Past Year

1

Class I (Serious)

0

Most Recent

Oct 2025

Data from FDA, USDA, CPSC, and NHTSA public records. Recall counts vary by company size, industry, and reporting practices. Always check official sources for current information.

Showing 1–9 of 9 recalls

NextSeq 550Dx Reagent Kits (Illumina) – Flow Cell Compatibility (2025)

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 exposure to user.

Moderate

FDAOct 28, 2025Nationwide• Illumina, Inc.

NextSeq 550Dx Instrument (Illumina) – Cybersecurity Vulnerability (2023)

Cybersecurity vulnerability concerning the software used for sequencing instruments.

High

FDAApr 5, 2023Nationwide• Illumina, Inc.

MiSeq Dx Instrument (Illumina) – Cybersecurity Vulnerability (2023)

Cybersecurity vulnerability concerning the software used for sequencing instruments.

High

FDA

Apr 5, 2023

Nationwide

• Illumina, Inc.

Illumina MiSeq Dx (Illumina) – Cybersecurity Vulnerability (2022)

cybersecurity vulnerability

Moderate

FDAMay 3, 2022Nationwide• Illumina, Inc.

NextSeq 550 Dx (Illumina) – cybersecurity vulnerability (2022)

cybersecurity vulnerability

Moderate

FDAMay 3, 2022Nationwide• Illumina, Inc.

NextSeq 550Dx (Illumina) – potential short circuit (2022)

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.

Moderate

FDAFeb 22, 2022AL, AZ, AR +28 more• Illumina, Inc.

MiSeqDx Universal Kit (Illumina) – Software Limitation (2014)

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 IIModerate

FDANov 13, 2014AZ, CA, GA +2 more• Illumina Inc

MiSeqDx Cystic Fibrosis Sequencing Assay (Illumina) – Software Limitation (2014)

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 IIILow

FDANov 6, 2014MD, NY• Illumina Inc