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Sentosa SQ301 Sequencer

VELA OPERATIONS SINGAPORE PTE. LTD. · Model 7468 · UDI-DI 08885013950045

510(k) clearances

Adverse events

Recalls

Facilities

Description

The Sentosa® SQ301 Platform is an in vitro diagnostic system composed of a sequencing instrument that measures the hydrogen ions that are generated during the incorporation of nucleotides in the DNA sequencing reaction and the ancillary instrumentation necessary for sample processing. This platform is used in conjunction with instrument-specific library preparation kits, template kits, sequencing kits, chip kits and data analysis software. The Sentosa® SQ301 Platform is intended for targeted sequencing of various biological samples. The Sentosa® SQ301 Platform is not intended for whole genome or de novo sequencing.

Recalls

Date	Firm	Reason
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
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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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.