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MiSeqDx Instrument
ILLUMINA, INC. · Model 15036706 · UDI-DI 00816270020002
PFF
Prescription
1
510(k) clearances
8
Adverse events
11
Recalls
11
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 |
|---|---|---|
| 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. |
| 2022-05-03 | Illumina, Inc. | cybersecurity vulnerability |
| 2022-05-03 | Illumina, Inc. | cybersecurity vulnerability |
| 2022-02-22 | Illumina, 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 |
| 2019-09-26 | Life Technologies Holdings Pte Ltd | 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 dete |
| 2019-09-26 | Life Technologies Holdings Pte Ltd | 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 dete |
| 2019-09-26 | Life Technologies Holdings Pte Ltd | 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 dete |
| 2019-09-26 | Life Technologies Holdings Pte Ltd | 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 dete |
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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.