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High Throughput Dna Sequence Analyzer

FDA product code PFF · Class 2 · Immunology

18
Registered devices
8
Adverse events
11
Recalls
2
510(k) clearances

Devices with this code

NovaSeq™ 6000Dx — ILLUMINA, INC.Sentosa ST401e — VELA OPERATIONS SINGAPORE PTE. LTD.Torrent Suite™ Dx SW, V5.6.4 — LIFE TECHNOLOGIES HOLDINGS PTE. LTD.Torrent Suite DX SW, Installer V5.14 — LIFE TECHNOLOGIES HOLDINGS PTE. LTD.Sentosa ST401i — VELA OPERATIONS SINGAPORE PTE. LTD.Torrent Suite DX, Installer v5.8 — LIFE TECHNOLOGIES HOLDINGS PTE. LTD.Ion One Touch™ ES Dx — LIFE TECHNOLOGIES HOLDINGS PTE. LTD.MiSeq™ Dx (China) — ILLUMINA, INC.Ion One Touch™ Dx — LIFE TECHNOLOGIES HOLDINGS PTE. LTD.Torrent Suite DX SW, Installer V5.14.2 — LIFE TECHNOLOGIES HOLDINGS PTE. LTD.Ion Torrent™ Genexus™ Dx Integrated Sequencer — LIFE TECHNOLOGIES HOLDINGS PTE. LTD.Sentosa SQ301 Sequencer — VELA OPERATIONS SINGAPORE PTE. LTD.Torrent Suite DX, Installer v5.12.5 — LIFE TECHNOLOGIES HOLDINGS PTE. LTD.Ion PGM™ Dx Chip Minifuge — LIFE TECHNOLOGIES HOLDINGS PTE. LTD.MiSeqDx Instrument — ILLUMINA, INC.Ion Torrent Genexus Dx Software — LIFE TECHNOLOGIES HOLDINGS PTE. LTD.NextSeq 550Dx Sequencing System — ILLUMINA, INC.Personal Genome Machine™ Dx (PGM™) Dx — LIFE TECHNOLOGIES HOLDINGS PTE. LTD.

Recent recalls

DateFirmReason
2024-02-07Life Technologies CorporationTorrent 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 the
2023-04-05Illumina, Inc.Cybersecurity vulnerability concerning the software used for sequencing instruments.
2023-04-05Illumina, Inc.Cybersecurity vulnerability concerning the software used for sequencing instruments.
2022-05-03Illumina, Inc.cybersecurity vulnerability
2022-05-03Illumina, Inc.cybersecurity vulnerability
2022-02-22Illumina, 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
2019-09-26Life Technologies Holdings Pte LtdTorrent SuiteTM Dx analysis software, a component of the Ion PGM Dx Instrument System, incorrectly displays a positive result when a different analytical or de
2019-09-26Life Technologies Holdings Pte LtdTorrent SuiteTM Dx analysis software, a component of the Ion PGM Dx Instrument System, incorrectly displays a positive result when a different analytical or de
2019-09-26Life Technologies Holdings Pte LtdTorrent SuiteTM Dx analysis software, a component of the Ion PGM Dx Instrument System, incorrectly displays a positive result when a different analytical or de
2019-09-26Life Technologies Holdings Pte LtdTorrent SuiteTM Dx analysis software, a component of the Ion PGM Dx Instrument System, incorrectly displays a positive result when a different analytical or de

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