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High Throughput Dna Sequence Analyzer
FDA product code PFF · Class 2 · Immunology
30
Registered devices
8
Adverse events
18
Recalls
2
510(k) clearances
Devices with this code
Ion One Touch™ Dx — LIFE TECHNOLOGIES HOLDINGS PTE. LTD.NovaSeq™ 6000Dx — ILLUMINA, INC.Ion PGM™ Dx Chip Minifuge — LIFE TECHNOLOGIES HOLDINGS PTE. LTD.Sentosa SQ301 Sequencer — VELA OPERATIONS SINGAPORE PTE. LTD.NextSeq 550Dx Sequencing System — ILLUMINA, INC.Genexus Dx Cartridge — LIFE TECHNOLOGIES CORPORATIONGenexus Dx Strip 3-GX5 — LIFE TECHNOLOGIES CORPORATIONGenexus Dx Barcodes 1-32 HD — LIFE TECHNOLOGIES CORPORATIONIon One Touch™ ES Dx — LIFE TECHNOLOGIES HOLDINGS PTE. LTD.Genexus Dx FFPE DNA and RNA Purification — LIFE TECHNOLOGIES CORPORATIONIon Torrent Genexus Dx Software — LIFE TECHNOLOGIES HOLDINGS PTE. LTD.Genexus Dx GX5 Chip and Genexus Coupler — LIFE TECHNOLOGIES CORPORATIONGenexus Dx Library Strip 1 — LIFE TECHNOLOGIES CORPORATIONMiSeqDx Instrument — ILLUMINA, INC.Sentosa ST401e — VELA OPERATIONS SINGAPORE PTE. LTD.Genexus Dx Library Strip 2-HD — LIFE TECHNOLOGIES CORPORATIONTorrent Suite™ Dx SW, V5.6.4 — LIFE TECHNOLOGIES HOLDINGS PTE. LTD.Torrent Suite DX, Installer v5.12.5 — LIFE TECHNOLOGIES HOLDINGS PTE. LTD.Torrent Suite DX SW, Installer V5.14 — LIFE TECHNOLOGIES HOLDINGS PTE. LTD.Torrent Suite DX SW, Installer V5.14.2 — LIFE TECHNOLOGIES HOLDINGS PTE. LTD.Sentosa ST401i — VELA OPERATIONS SINGAPORE PTE. LTD.Genexus Dx Purification Supplies 2 — LIFE TECHNOLOGIES CORPORATIONGenexus Dx Bottle 2 — LIFE TECHNOLOGIES CORPORATIONGenexus Dx Strip 4 — LIFE TECHNOLOGIES CORPORATION
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-08-14 | Life Technologies Holdings Pte Ltd | DNA or RNA sequencing system software has vulnerabilities. |
| 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 ass |
| 2024-05-08 | Illumina, Inc. | (Retrospectively reported) Cybersecurity vulnerability identified in communication protocol between the customer-provided infrastructure (network storage, serve |
| 2024-05-08 | Illumina, Inc. | (Retrospectively reported) Cybersecurity vulnerability identified in communication protocol between the customer-provided infrastructure (network storage, serve |
| 2024-05-08 | Illumina, Inc. | (Retrospectively reported) Cybersecurity vulnerability identified in communication protocol between the customer-provided infrastructure (network storage, serve |
| 2024-05-08 | Illumina, Inc. | (Retrospectively reported) Cybersecurity vulnerability identified in communication protocol between the customer-provided infrastructure (network storage, serve |
| 2024-05-08 | Illumina, Inc. | (Retrospectively reported) Cybersecurity vulnerability identified in communication protocol between the customer-provided infrastructure (network storage, serve |
| 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 the |
| 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. |
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