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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 Recall
Verigene Warfarin Metabolism Nucleic Acid Test Cartridge
see related information
Date Posted March 31, 2008
Recall Status1 Terminated on May 17, 2010
Recall Number Z-1383-2008
Recall Event ID 46882
Premarket Notification
510(K) Number
Product Classification Cytochrome P450 2c9 (Cyp450 2c9) Drug Metabolizing Enzyme Genotyping System - 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/
Nanosphere, Inc.
4088 Commercial Ave
Northbrook, Illinois 60062-1829
For Additional Information Contact Gregory W. Shipp, M.D.
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
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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = ODW and Original Applicant = NANOSPHERE, INC