U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
데이터 추가 비고
Reagents for molecular diagnostic test systems - Product Code PFS
원인
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.
조치
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.
US Distribution to the states of AZ, GA, CA, OH, and VA., and one Internationally to France.
제품 설명
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.