High Throughput Dna Sequence Analyzer
Immunology · 21 CFR 862.2265
A high throughput sequencing technology performing targeted DNA sequencing of amplicons from a defined genetic region or a subset of genes in human genomic DNA from a clinical sample.
Recent MDR events
8 adverse event reports on file
- ILLUMINA NEXTSEQ¿ 550DX INSTRUMENTJun 15, 2026InjuryIllumina Singapore3007102730-2026-00001
- WHOLE GENOME SEQUENCING, SEQUENCING.COMSep 30, 2025MalfunctionUnkMW5176790
- ILLUMINA MISEQDX INSTRUMENTSep 10, 2025InjuryIllumina Hayward3005095756-2025-00001
- ILLUMINA NEXTSEQ¿ 550DX INSTRUMENTMay 28, 2024MalfunctionIllumina Singapore3007102730-2024-00001
- ILLUMINA NEXTSEQ¿ 550DX INSTRUMENTJun 6, 2023MalfunctionIllumina Singapore3007102730-2023-00001
- ILLUMINA NEXTSEQ¿ 550DX INSTRUMENTJun 15, 2022MalfunctionIllumina Singapore3007102730-2022-00001
- ILLUMINA NEXTSEQ¿ 550DX INSTRUMENTNov 23, 2021InjuryIllumina Singapore3007102730-2021-00001
- VERIFI DAN TESTMar 13, 2015OtherMW5041521
Event type breakdown
Most-reported manufacturers
Recalls
11 recall events for this product code
- Life Technologies CorporationOpen, ClassifiedMar 29, 2024
Torrent Suite Dx Software versions 5.14 and earlier used in connection with Ion PGM DX Systems-IVD intended for targeted sequencing of human genomic DNA (gDNA)
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, configurations, software, or data on the instrument
Z-1426-2024 · View FDA record ↗ - Illumina, Inc.CompletedJun 16, 2023
NextSeq 550Dx Instrument, Catalog # 20005715, contaning Universal Copy Service software
Cybersecurity vulnerability concerning the software used for sequencing instruments.
Z-1976-2023 · View FDA record ↗ - Illumina, Inc.CompletedJun 16, 2023
MiSeq Dx Instrument, Catalog # M70101, containing Universal Copy Service (UCS) software.
Cybersecurity vulnerability concerning the software used for sequencing instruments.
Z-1977-2023 · View FDA record ↗ - Illumina IncTerminatedSep 9, 2014
Illumina Worklist Manager (IWM) (software v1.0.15), a component of Illumina MiSeqDx Platform.
A software component of the MiSeqDx instrument, called the Illumina Worklist Manager (IWM) v1.0.15, fails to perform as intended
Z-2611-2014 · View FDA record ↗ - Life Technologies Holdings Pte LtdTerminatedUnknown
Torrent Suite Dx Software Version (IUO) 5.2
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 detected at the same locus as a specified clinical variant
Z-0185-2020 · View FDA record ↗ - Life Technologies Holdings Pte LtdTerminatedUnknown
Torrent Suite Dx Software Version (IUO) 5.4
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 detected at the same locus as a specified clinical variant
Z-0186-2020 · View FDA record ↗ - Life Technologies Holdings Pte LtdTerminatedUnknown
Torrent Suite Dx Software Version 5.6.4
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 detected at the same locus as a specified clinical variant
Z-0187-2020 · View FDA record ↗ - Life Technologies Holdings Pte LtdTerminatedUnknown
Torrent Suite Dx Software Version 5.8
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 detected at the same locus as a specified clinical variant
Z-0188-2020 · View FDA record ↗ - Illumina, Inc.CompletedUnknown
Illumina NextSeq 550Dx, REF: 20005715, CE, IVD
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.
Z-0854-2022 · View FDA record ↗ - Illumina, Inc.CompletedUnknown
illumina REF DX-410-1001 Model: MiSeq Dx
cybersecurity vulnerability
Z-1259-2022 · View FDA record ↗
Registered firms
13 firms currently registered for this product code
Life Technologies Corporation
S San Fran, CA, US
Life Technologies Corporation
Guilford, CT, US
Sts Corporation
Duluth, GA, US
Illumina, Inc.
San Diego, CA, US
Life Technologies Corporation
Carlsbad, CA, US
Life Technologies Corporation
Austin, TX, US
Vela Operations Singapore Pte Ltd
Singapore Central Singapore, SG
Illumina Singapore Pte. Ltd.
Singapore Central Singapore, SG
Illumina, Inc. Hayward
Hayward, CA, US
Life Technologies Holdings Pte Ltd.
SINGAPORE North West, SG
Life Technologies Corporation
FREDERICK, MD, US
510(k) clearances
2 clearances for this product code