NextSeq 550Dx Sequencing System
ILLUMINA, INC. · Model 20005715 · UDI-DI 00816270020125
Description
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 strands. Instrument software performs image analysis and base calling, assigning a quality score to each base for each sequencing cycle. When primary analysis finishes, secondary analysis processes base calls on the instrument. The NextSeq 550Dx instrument uses different secondary analysis modules depending on the workflow. For the germline or somatic variant calling modules, data processing includes de-multiplexing, FASTQ file generation, alignment, variant calling, and generation of variant call format (VCF) files containing information regarding variants found at specific positions in a reference genome.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2024-09-17 | Illumina, Inc. | 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 wit |
| 2024-02-07 | Life Technologies Corporation | Torrent Suite Dx Software versions 5.14 and earlier used in connection with Ion PGM DX Systems exploitation of the vulnerability by a threat actor may allow them to alter settings, |
| 2023-04-05 | Illumina, Inc. | Cybersecurity vulnerability concerning the software used for sequencing instruments. |
| 2023-04-05 | Illumina, Inc. | Cybersecurity vulnerability concerning the software used for sequencing instruments. |
| 2022-05-03 | Illumina, Inc. | cybersecurity vulnerability |
| 2022-05-03 | Illumina, Inc. | cybersecurity vulnerability |
| 2022-02-22 | Illumina, Inc. | 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 reconn |
| 2019-09-26 | Life Technologies Holdings Pte Ltd | Torrent SuiteTM Dx analysis software, a component of the Ion PGM Dx Instrument System, incorrectly displays a positive result when a different analytical or de novo variant is dete |
| 2019-09-26 | Life Technologies Holdings Pte Ltd | Torrent SuiteTM Dx analysis software, a component of the Ion PGM Dx Instrument System, incorrectly displays a positive result when a different analytical or de novo variant is dete |
| 2019-09-26 | Life Technologies Holdings Pte Ltd | Torrent SuiteTM Dx analysis software, a component of the Ion PGM Dx Instrument System, incorrectly displays a positive result when a different analytical or de novo variant is dete |
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