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Illumina Inc recalls Illumina MiSeqDx Universal Kit 1.0, PN 15039608 The Illumina MiSeqDx Universal Kit 1.0 is a set of reagents and consu
Recalled December 31, 2014 · FDA recall Z-0849-2015 · Illumina
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. · FDA Class II
Units
13 units
Sold at
US Distribution to the states of AZ, GA, CA, OH, and VA., and one Internationally to France.
Description
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.
Product
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.
Manufacturer(s)
Illumina Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →