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U.S. Department of Health and Human Services

Class 3 Device Recall Illumina MiSeqDx Cystic Fibrosis Clinical Sequencing Assay

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  Class 3 Device Recall Illumina MiSeqDx Cystic Fibrosis Clinical Sequencing Assay see related information
Date Initiated by Firm November 06, 2014
Date Posted December 23, 2014
Recall Status1 Terminated 3 on March 17, 2015
Recall Number Z-0850-2015
Recall Event ID 69715
510(K)Number K132750  
Product Classification System, cystic fibrosis transmembrane conductance regulator gene, variant gene sequence detection - Product Code PFS
Product Illumina MiSeqDx Cystic Fibrosis Clinical Sequencing Assay in vitro diagnostic system for use on the Illumina MiSeqDx Platform.
Code Information Instrument Serial No. M70106, M00533L, M70114. Lot No. Shipped: K103313, K103461, K103404, K103487.
Recalling Firm/
Manufacturer		 Illumina Inc
5200 Illumina Way
San Diego CA 92121
For Additional Information Contact
858-736-3861
Manufacturer Reason
for Recall		 Illumina has confirmed a software limitation with MiSeq Reporter software (version 2.2.31) when using the MiSeqDx Cystic Fibrosis Clinical Sequencing Assay on the MiSeqDx instrument.
FDA Determined
Cause 2		 Under Investigation by firm
Action A customer notification letter dated 11/12/14 was sent to all customers who purchased the MiSeqDx Cystic Fibrosis Clinical Sequencing Assay. The letter confirms that there is a software limitation with MiSeq Reporter software (version 2.2.31) when using the MiSeqDx Cystic Fibrosis Clinical Sequencing Assay on the MiSeqDx instrument. At certain genomic locations within the region sequenced by the assay, deletions cannot be reported by the software. The letter outlines the potential issues, the results of Illuminia's investigation, and the firm's next steps. 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. Customers will be contacted by 11/13/14 by phone and a phone script was provided that includes the procedure, talking points, actions required, and next steps.
Quantity in Commerce 19 units
Distribution US: MD, NY Non-US: 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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