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U.S. Department of Health and Human Services

Class 2 Device Recall Verigene Warfarin Metabolism Nucleic Acid Test Cartridge

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  Class 2 Device Recall Verigene Warfarin Metabolism Nucleic Acid Test Cartridge see related information
Date Initiated by Firm February 25, 2008
Date Posted March 31, 2008
Recall Status1 Terminated 3 on May 17, 2010
Recall Number Z-1383-2008
Recall Event ID 46882
510(K)Number K070804  
Product Classification Verigene Warfarin Metabolism Nucleic Acid Test Cartridge - Product Code ODW
Product Warfarin Metabolism Nucleic Acid Test Cartridge; Part Number: 20-006-002; an in vitro diagnostic drug metabolizing enzyme genotyping system; Nanosphere, Inc., 4088 Commercial Ave., Northbrook, IL 60062
Code Information Lot Numbers 121907002B, 010708002A, 012108002A, 012108002C, 012208002C, 012408002B, 012808002A, and 020608002A
Recalling Firm/
Manufacturer		 Nanosphere, Inc.
4088 Commercial Ave
Northbrook IL 60062-1829
For Additional Information Contact Gregory W. Shipp, M.D.
847-400-9115
Manufacturer Reason
for Recall		 Aberrant Results: A warfarin 2C9*2 mutant capture signal was found to be high enough to result in an aberrant result (i.e., wild-type called heterozygous).
FDA Determined
Cause 2		 Other
Action Nanosphere sent Urgent Device Recall letters dated 2/25/08 to the direct accounts on the same date, informing them of the potential for aberrant results with the use of the affected lots of cartridges. The accounts were requested to examine their stocks for the affected lots of cartridges, segregate those found and return them to Nanosphere for replacement. Any questions can be directed to Dr. Gregg Shipp at 847-400-9115.
Quantity in Commerce 624 units
Distribution Nationwide; USA including states of Kentucky, Michigan, Tennessee, Texas, Louisiana, Connecticut, Illinois, and California.
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 = ODW and Original Applicant = NANOSPHERE, INC
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