MiSeqDx Instrument 15036706Recalls & reported problems
Illumina, Inc. · 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. · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 2
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00816270020002), received between Sep 10, 2025 and Sep 10, 2025 — classified as 1 injury.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (1 report).
2 FDA recall records name this device's identifier.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Recalls naming this device
- Apr 5, 2023Class IICompleted
Cybersecurity vulnerability concerning the software used for sequencing instruments.
Z-1977-2023 · Root cause: Software Manufacturing/Software Deployment · Recall details · FDA record ↗
- May 3, 2022Class IICompleted
cybersecurity vulnerability
Z-1259-2022 · Root cause: Software in the Use Environment · Recall details · FDA record ↗
Most reported problems
Device problems
- Insufficient Device Problem Information1
Patient problems
- Burn(s)1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjurySep 10, 2025Insufficient Device Problem Information; Insufficient Device Problem Information
THE IMPACTED PRODUCT IS THE MISEQ SYSTEM, WHICH IS A RESEARCH USE ONLY (RUO) PRODUCT. THIS PRODUCT IS LIKE OR SIMILAR TO THE MISEQDX INSTRUMENT IN VITRO DIAGNOSTIC (IVD). THE SEQUENCING BY SYNTHESIS (SBS) CHEMISTRY FOR THE RUO INSTRUMENT IS SIMILAR TO THE IVD INSTRUMENT, THEREFORE, THIS EVENT IS BEING REPORTED AS AN MDR. NOTE: INDIVIDUAL FORMULATIONS MAY DIFFER SOMEWHAT. THE MISEQDX INSTRUMENT IS INTENDED FOR TARGETED SEQUENCING OF DNA LIBRARIES FROM HUMAN GENOMIC DNA EXTRACTED FROM PERIPHERAL WHOLE BLOOD OR FORMALIN-FIXED, PARAFFIN-EMBEDDED (FFPE) TISSUE, WHEN USED WITH IN VITRO DIAGNOSTIC (IVD) ASSAYS PERFORMED ON THE INSTRUMENT. 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. ON AUGUST 20, 2025, AN ILLUMINA FIELD SAFETY ENGINEER (FSE) WAS AT THE CUSTOMER SITE TO PERFORM OPTICAL ADJUSTMENT WHILE INSTALLING A NEW SOLID STATE DRIVE (SSD). DURING INSTALLATION, THE FSE OBSERVED SMOKE AND BROWN DISCOLORATION ON THE CABLE AS WELL AS A BURNT HOLE IN THE BLACK OUT CLOTH. THE SOURCE WAS TRACED TO A FLOW SENSOR CABLE. THE CABLE WAS THEN
Patient problems: Burn(s)
MAUDE report 23023144 ↗
Other High Throughput Dna Sequence Analyzer devices
- NextSeq 550Dx Sequencing System 20005715Illumina, Inc. · High Throughput Dna Sequence Analyzer4 recalls3 reports
- NovaSeq™ 6000Dx 20068232Illumina, Inc. · High Throughput Dna Sequence Analyzer1 recall0 reports
- Torrent Suite DX SW, Installer V5.14 A52422Life Technologies Holdings Pte. Ltd. · High throughput DNA sequence analyzer1 recall0 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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