Recall Z-2611-2014— Illumina Inc
Class II · Terminated
Class II FDA medical device recall by Illumina Inc, initiated 2014-07-28, terminated 2014-11-12. FDA's recall record names no specific 510(k) clearance for this event. 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.. Reason: A software component of the MiSeqDx instrument, called the Illumina Worklist Manager (IWM) v1.0.15, fails to perform as intended.
- Recalling firm
- Illumina Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2014-07-28
- Terminated
- 2014-11-12
- Firm location
- San Diego, CA, United States
Product description
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.
Reason for recall
A software component of the MiSeqDx instrument, called the Illumina Worklist Manager (IWM) v1.0.15, fails to perform as intended
Data sourced from openFDA. This site is unofficial and independent of the FDA.