FDAFDA · Food and drugs·Recall number Z-0849-2015
Illumina MiSeqDx Universal Kit 1.0, PN 15039608 The Illumina MiSeqDx Universal Kit 1.0 is a set of reagents and consumables used in the processing of human genomic DNA samples derived from peripheral whole blood, and in the subsequent targeted sequencing of the resulting sample libraries. User-supplied analyte specific reagents are required for the preparation of libraries targeting specific genomic regions of interest. The MiSeqDx Universal Kit 1.0 is intended for use with the MiSeqDx instrument.
Published December 31, 2014 · Recall initiated: November 13, 2014
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
It was discovered a software limitation with MiSeq Reporter software (version 2.2.31) when using the MiSeqDx Universal Kit 1.0 on the MiSeqDx instrument. The software cannot report insertions or deletions at specific genomic locations with respect to the primer.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Illumina Inc
- Distributor
- US Distribution to the states of AZ, GA, CA, OH, and VA., and one Internationally to France.
- Lot
- Serial No. M70130, M70189, M70108, M70165, M70166, M70175, M70172, M70103.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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