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U.S. Department of Health and Human Services

Class 2 Device Recall llumina MiSeqDx (used with Worklist Manager (IWM) software v1.0.15)

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  Class 2 Device Recall llumina MiSeqDx (used with Worklist Manager (IWM) software v1.0.15) see related information
Date Initiated by Firm July 28, 2014
Date Posted September 09, 2014
Recall Status1 Terminated 3 on November 12, 2014
Recall Number Z-2611-2014
Recall Event ID 68959
510(K)Number K123989  
Product Classification High throughput DNA sequence analyzer - Product Code PFF
Product Illumina Worklist Manager (IWM) (software v1.0.15), a component of Illumina MiSeqDx Platform.

Product Usage: The Illumina MiSeqDx is a sequencing instrument that measures fluorescence signals of labeled nucleotides through the use of instrument specific reagents and flow cells (MiSeqDx Universal Kit 1.0), imaging hardware, and data analysis software. The MiSeqDx Platform is intended for targeted sequencing of human genomic DNA from peripheral whole blood samples.
Code Information M70113 M70144 M70131 M70138 M70143 M70119 M70134 M70156 M70103 M70123 M70159 M70153 M70136 M70102 M70137 M70130 M00533L M70139 M70132 M70160 M70106 M70135 M70107 M70104 M70108 M70157 M70105 M70165 M70116 M70172 M70166 M70114 M70158 M70109 M70115
Recalling Firm/
Manufacturer		 Illumina Inc
5200 Illumina Way
San Diego CA 92121
For Additional Information Contact
858-736-3861
Manufacturer Reason
for Recall		 A software component of the MiSeqDx instrument, called the Illumina Worklist Manager (IWM) v1.0.15, fails to perform as intended
FDA Determined
Cause 2		 Device Design
Action Illumina notified affected customers via phone, email and Product Quality Notification letter dated July 28, 2014 to describe the software anomaly. The letter identified the affected product, problem and actions to be taken. For questions contact your local support team or Illumina Technical Support at techsupport@illumina.com.
Quantity in Commerce 35
Distribution Worldwide Distribution - US (nationwide) and the countries of: France, Germany, Italy, Norway, UK and United Arab Emirates.
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.
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