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MiSeqDx Instrument
ILLUMINA, INC. · Model 15036706 · UDI-DI 00816270020002
PFF
Prescription
1
510(k) clearances
8
Adverse events
18
Recalls
13
Facilities
Description
The Illumina MiSeqDx is a sequencing instrument that measures fluorescence signals of labeled nucleotides through the use of instrument specific reagents and flow cells (MiSeqDx Universal Kit 1.0), imaging hardware, and data analysis 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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Get your free API keyRead the docsData 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.