Company: Illumina, Inc.
Date of Enforcement Report: 9/17/2014
Class lI:
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. Recall Number Z-2611-2014
REASON
A software component of the MiSeqDx instrument, called the Illumina Worklist Manager (IWM) v1.0.15, fails to perform as intended.
RECALLING FIRM/MANUFACTURER
Illumina Inc., San Diego, CA on 7/28/2014 Voluntary: Firm Initiated recall is ongoing
VOLUME OF PRODUCT IN COMMERCE
35
DISTRIBUTION
Nationwide and Internationally
___________________________________
