Home / Recalls / Medical Devices
Illumina Inc recalls Illumina Worklist Manager (IWM) (software v1.0.15), a component of Illumina MiSeqDx Platform. Product Usage: The Illu
Recalled September 17, 2014 · FDA recall Z-2611-2014 · Illumina
Hazard
A software component of the MiSeqDx instrument, called the Illumina Worklist Manager (IWM) v1.0.15, fails to perform as intended · FDA Class II
Units
35
Sold at
Worldwide Distribution - US (nationwide) and the countries of: France, Germany, Italy, Norway, UK and United Arab Emirates.
Description
A software component of the MiSeqDx instrument, called the Illumina Worklist Manager (IWM) v1.0.15, fails to perform as intended
Product
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.
Manufacturer(s)
Illumina Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →