Reported Sep 17, 2014 · Terminated
Illumina Worklist Manager (IWM) (software v1.0.15), a component of Illumina MiSeqDx Platform. Product Usage: The…
Illumina Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Illumina Inc · 5200 Illumina Way · San Diego, CA · 92121
Is this the product you have?
- Illumina Worklist Manager (IWM) (software v1.0.15), a component of Illumina MiSeqDx Platform
- Product UsageThe 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
- Lot codes and dates
M70113M70144M70131M70138M70143M70119M70134M70156M70103M70123M70159M70153M70136M70102M70137M70130M00533LM70139M70132M70160M70106M70135M70107M70104M70108M70157M70105M70165M70116M70172M70166M70114M70158M70109M70115
- Amount recalled
- 35
Where it was sold
- Nationwide
Why it was recalled
A software component of the MiSeqDx instrument, called the Illumina Worklist Manager (IWM) v1.0.15, fails to perform as intended
This product could cause temporary or reversible health problems — stop using it.
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