Z-0849-2015 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- December 31, 2014
- Initiation Date
- November 13, 2014
- Termination Date
- March 18, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 13 units
Product Description
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.
Reason for Recall
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.
Distribution Pattern
US Distribution to the states of AZ, GA, CA, OH, and VA., and one Internationally to France.
Code Information
Serial No. M70130, M70189, M70108, M70165, M70166, M70175, M70172, M70103.