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Personal Genome Machine™ Dx (PGM™) Dx

LIFE TECHNOLOGIES HOLDINGS PTE. LTD. · Model 7469 · UDI-DI 10190302000833

PFF Prescription
2
510(k) clearances
8
Adverse events
11
Recalls
11
Facilities

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 them to alter settings,
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 insufficient reconn
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 novo variant is dete
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 novo variant is dete
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 novo variant is dete
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 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.