Illumina Recalls
9 recalls on record · September 17, 2014 to December 10, 2025 · Medical Devices
Recalls by year
14
22
23
25
Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
December 10, 2025Medical DevicesFDA
Illumina, Inc. recalls Reagent Kits/ containing flow cells, components of NextSeq 550Dx Instrument: NextSeq 550Dx High Output Reagent Kit v2.5
Hazard: 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.
June 28, 2023Medical DevicesFDA
Illumina, Inc. recalls MiSeq Dx Instrument, Catalog # M70101, containing Universal Copy Service (UCS) software.
Hazard: Cybersecurity vulnerability concerning the software used for sequencing instruments.
June 28, 2023Medical DevicesFDA
Illumina, Inc. recalls NextSeq 550Dx Instrument, Catalog # 20005715, contaning Universal Copy Service software
Hazard: Cybersecurity vulnerability concerning the software used for sequencing instruments.
June 22, 2022Medical DevicesFDA
Illumina, Inc. recalls illumina Model NextSeq 550 Dx REF 20005715
Hazard: cybersecurity vulnerability
June 22, 2022Medical DevicesFDA
Illumina, Inc. recalls illumina REF DX-410-1001 Model: MiSeq Dx illumina REF 15036706 Model: MiSeq Dx illumina REF 20014053 Model: MiSeq
Hazard: cybersecurity vulnerability
April 6, 2022Medical DevicesFDA
Illumina, Inc. recalls Illumina NextSeq 550Dx, REF: 20005715, CE, IVD
Hazard: 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.
December 31, 2014Medical DevicesFDA
Illumina Inc recalls Illumina MiSeqDx Cystic Fibrosis Clinical Sequencing Assay in vitro diagnostic system for use on the Illumina MiSeqDx P
Hazard: 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.
December 31, 2014Medical DevicesFDA
Illumina Inc recalls Illumina MiSeqDx Universal Kit 1.0, PN 15039608 The Illumina MiSeqDx Universal Kit 1.0 is a set of reagents and consu
Hazard: 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.
September 17, 2014Medical DevicesFDA
Illumina Inc recalls Illumina Worklist Manager (IWM) (software v1.0.15), a component of Illumina MiSeqDx Platform. Product Usage: The Illu
Hazard: A software component of the MiSeqDx instrument, called the Illumina Worklist Manager (IWM) v1.0.15, fails to perform as intended