Company: Illumina Inc.
Date of Enforcement Report 12/31/2014
Class lI:
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.
Recall Number Z-0849-2015
REASON
t 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..
RECALLING FIRM/MANUFACTURER
Illumina Inc, San diego, CA, on 11/13/2014. Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
13 units
DISTRIBUTION
US Distribution to the states of AZ, GA, CA, OH, and VA., and one Internationally to France.
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