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.
This recall has been terminated (originally issued December 23, 2014).
- Company
- Illumina, Inc.
- Recall Initiated
- November 13, 2014
- Posted
- December 23, 2014
- Terminated
- March 18, 2015
- Recall Number
- Z-0849-2015
- Quantity
- 13 units
- Firm Location
- San Diego, CA
- Official Source
- View on FDA website ↗
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
US Distribution to the states of AZ, GA, CA, OH, and VA., and one Internationally to France.
Lot / Code Info
Serial No. M70130, M70189, M70108, M70165, M70166, M70175, M70172, M70103.
Root Cause
Software design
Action Taken
A customer letter dated November 13, 2014, was sent to all customers who is using the MiSeqDx Universal Kit 1.0 on the MiSeqDx instrument. The letter informs the customers that Illumina has recently confirmed 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. The customer notification outlines the potential issues, the results of investigation, actions required, and next steps. Customers are instructed to return the attached Verification form to confirm their receipt of the letter and document the results of any patient impact from the limitation. Customers with technical questions or concerns, are instructed to contact their local support team or Illumina Technical Support at techsupport@illumina.com. Customers with questions regarding the field action, are instructed to contact Illumina Regulatory Affairs at RA@illumina.com. For further questions, please call (858) 736-3861.