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U.S. Department of Health and Human Services

Class 3 Device Recall Nanosphere Verigene CYP2C19 Nucleic Acid Test

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  Class 3 Device Recall Nanosphere Verigene CYP2C19 Nucleic Acid Test see related information
Date Initiated by Firm March 18, 2014
Date Posted August 28, 2014
Recall Status1 Terminated 3 on July 02, 2015
Recall Number Z-2559-2014
Recall Event ID 68710
510(K)Number K120466  
Product Classification Drug metabolizing enzyme genotyping systems - Product Code NTI
Product Verigene CYP2C19 Nucleic Acid Test (CYP2C19 Test). Each CYP2C19 kit consists of 20 Verigene CYP2C19 Nucleic Acid Test Cartridges and 20 Verigene CYP2C19 Nucleic Acid Extraction Trays (with Tip Holder Assemblies). Clinical laboratory test.
Code Information (Catalog No. 20-005-019)    Kit Numbers (US Distribution): 051013019-9, 6288-1, 6547-1, 6420-1, 5478-1, 5802-1, 6190-1, 7360-3, 5452-2, 6499-1, 6414-1, 7183-1, 7511-1, 5225-1, 5225-2, 6495-1, 5760-1, 5779-1, 7259-1, 6783-1, 7435-1    Kit Numbers (Foreign Distribution): 7300-4, 5500-1, 5908-3, 5970-3, 6402-1, 6402-2, 6105-1, 6123-1, 6793-1, 6827-1, 6224-1  
Recalling Firm/
Manufacturer		 Nanosphere, Inc.
4088 Commercial Ave
Northbrook IL 60062-1829
For Additional Information Contact Technical Support
888-837-4436 Ext. 2
Manufacturer Reason
for Recall		 Nanosphere has recieved reports related to an unacceptable increase in initial no-call rate when performing the Verigene CYP2C19 Nucleic Acid Test (2C19), which has been confirmed through internal testing.
FDA Determined
Cause 2		 Under Investigation by firm
Action Nanosphere sent an Field Notification Letter dated March 18, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The letters included instructions for customers to: 1) discontinue use of the affected products, 2) discard the affected product, and 3) complete and return the attached for to obtain free-of-charge replacement kits. Customers with any questions about this recall should contact their Nanosphere technical support representative at 1 888 837-4436. .
Quantity in Commerce 78 kits
Distribution Worldwide Distribution - US including the states of AL, CA, MD, ND, NJ, OK and TX., and internationally to Bulgaria, China and New Zealand.
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 = NTI and Original Applicant = NANOSPHERE, INC
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