ILLUMINA INC
NEXTSEQ 550DX · Chemistry
Related Cybersecurity Alerts
Recalls (4)
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.
Retrospectively reported correction for an instrument intended for targeted sequencing of DNA libraries from human genomic DNA used with in vitro diagnostic assays has a server with a security vulnerability.
Cybersecurity vulnerability concerning the software used for sequencing instruments.
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.
UDI Registrations (2)
The Illumina NextSeq 550Dx instrument is intended for sequencing DNA libraries prepared by adding sample indices and capture sequences to amplified targets. These libraries are captured on a flow cell and sequenced on the instrument using sequencing by synthesis (SBS) chemistry. SBS chemistry uses a reversible-terminator method to detect single nucleotide bases incorporated into growing DNA strand…
The DRAGEN™ for Illumina® DNA Prep with Enrichment Dx application for NextSeq 550Dx is used for sequencing run setup, run monitoring, primary and secondary analysis on the NextSeq 550Dx instrument for the Illumina® DNA Prep with Enrichment Dx library preparation assay. The software (SW) includes the UDI information in the User Interface.
FDA Classification (67)
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