FDA-Device2014-09-17Class II
Illumina Worklist Manager (IWM) (software v1.0.15), a component of Illumina MiSeqDx Platform. Product Usage: 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. The MiSeqDx Platform is intended for targeted sequencing of human genomic DNA from peripheral whole blood samples.
Illumina Inc
Hazard
A software component of the MiSeqDx instrument, called the Illumina Worklist Manager (IWM) v1.0.15, fails to perform as intended
Sold states
Worldwide Distribution - US (nationwide) and the countries of: France, Germany, Italy, Norway, UK and United Arab Emirates.
Affected count
35
Manufactured in
5200 Illumina Way, N/A, San Diego, CA, United States
Products
Illumina Worklist Manager (IWM) (software v1.0.15), a component of Illumina MiSeqDx Platform. Product Usage: 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. The MiSeqDx Platform is intended for targeted sequencing of human genomic DNA from peripheral whole blood samples.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2611-2014Don't want to check this manually?
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