BEUDAMED
    FDA Recall Terminated

    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: Z-0849-2015 · Initiated November 13, 2014

    Recall

    Recall Number
    Z-0849-2015
    Event Number
    69766
    Firm
    Illumina Inc
    FEI Number
    3003218906
    Product Code
    PFS
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    November 13, 2014
    Posted
    December 23, 2014
    Terminated
    March 18, 2015
    Address
    5200 Illumina Way, San Diego, CA, 92121

    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

    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.

    Action

    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 [email protected]. Customers with questions regarding the field action, are instructed to contact Illumina Regulatory Affairs at [email protected]. For further questions, please call (858) 736-3861.

    Distribution

    US Distribution to the states of AZ, GA, CA, OH, and VA., and one Internationally to France.

    Quantity

    13 units