Illumina Recalls

6 recalls on record in the United States

medical: 6
medical Class II
2025-12-10

Illumina, Inc. recalls Reagent Kits/ containing flow cells, components of NextSeq 5

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.

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medical Class II
2023-06-28

Illumina, Inc. recalls MiSeq Dx Instrument, Catalog # M70101, containing Universal

Cybersecurity vulnerability concerning the software used for sequencing instruments.

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medical Class II
2023-06-28

Illumina, Inc. recalls NextSeq 550Dx Instrument, Catalog # 20005715, contaning Univ

Cybersecurity vulnerability concerning the software used for sequencing instruments.

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medical Class II
2022-06-22

Illumina, Inc. recalls illumina Model NextSeq 550 Dx REF 20005715

cybersecurity vulnerability

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medical Class II
2022-06-22

Illumina, Inc. recalls illumina REF DX-410-1001 Model: MiSeq Dx illumina REF 150

cybersecurity vulnerability

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medical Class II
2022-04-06

Illumina, Inc. recalls 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.

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