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.
Enforcement
- Recall Number
- Z-0849-2015
- Event ID
- 69766
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Illumina Inc
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- December 31, 2014
- Initiation Date
- November 13, 2014
- Classification Date
- December 23, 2014
- Termination Date
- March 18, 2015
- Address
- 5200 Illumina Way, San Diego, CA, 92121, United States
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.
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.
Serial No. M70130, M70189, M70108, M70165, M70166, M70175, M70172, M70103.
US Distribution to the states of AZ, GA, CA, OH, and VA., and one Internationally to France.
13 units