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U.S. Department of Health and Human Services

Class 2 Device Recall MiSeqDx Universal Kit 1.0

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  Class 2 Device Recall MiSeqDx Universal Kit 1.0 see related information
Date Initiated by Firm November 13, 2014
Date Posted December 23, 2014
Recall Status1 Terminated 3 on March 18, 2015
Recall Number Z-0849-2015
Recall Event ID 69766
510(K)Number K132750  
Product Classification Reagents for molecular diagnostic test systems - Product Code PFS
Product 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.
Code Information Serial No. M70130, M70189, M70108, M70165, M70166, M70175, M70172, M70103. 
Recalling Firm/
Manufacturer		 Illumina Inc
5200 Illumina Way
San Diego CA 92121
For Additional Information Contact
858-736-3861
Manufacturer 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.
FDA Determined
Cause 2		 Software design
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 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.
Quantity in Commerce 13 units
Distribution US Distribution to the states of AZ, GA, CA, OH, and VA., and one Internationally to France.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = PFS and Original Applicant = ILLUMINA, INC.
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