MiSeq™ Dx (China)
ILLUMINA, INC. · Model 20014053 · UDI-DI 00816270020699
Description
The Illumina MiSeqDx is intended for targeted sequencing of human DNA using Illumina sequencing consumables and libraries prepared from human genomic DNA extracted from peripheral whole blood or formalin-fixed, paraffin-embedded (FFPE) tissue. Libraries are prepared by amplifying targets and adding sample indexes and capture sequences. Sample libraries are captured on a flow cell and sequenced on the instrument using sequencing by synthesis (SBS) chemistry. SBS chemistry uses a reversible-terminator method to detect single nucleotide bases as they are incorporated into growing DNA strands. The Real-Time Analysis (RTA) software performs image analysis and base calling, and assigns a quality score to each base for each sequencing cycle. The MiSeqDx instrument is not intended for whole genome or de novo sequencing. The MiSeqDx instrument is to be used with registered and listed, cleared, or approved IVD reagents and analytical software.
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 assays has a server wit |
| 2024-05-08 | Illumina, Inc. | (Retrospectively reported) Cybersecurity vulnerability identified in communication protocol between the customer-provided infrastructure (network storage, servers, or computers) an |
| 2024-05-08 | Illumina, Inc. | (Retrospectively reported) Cybersecurity vulnerability identified in communication protocol between the customer-provided infrastructure (network storage, servers, or computers) an |
| 2024-05-08 | Illumina, Inc. | (Retrospectively reported) Cybersecurity vulnerability identified in communication protocol between the customer-provided infrastructure (network storage, servers, or computers) an |
| 2024-05-08 | Illumina, Inc. | (Retrospectively reported) Cybersecurity vulnerability identified in communication protocol between the customer-provided infrastructure (network storage, servers, or computers) an |
| 2024-05-08 | Illumina, Inc. | (Retrospectively reported) Cybersecurity vulnerability identified in communication protocol between the customer-provided infrastructure (network storage, servers, or computers) an |
| 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. |
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