Nanosphere, Inc. 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 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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
Brand
Nanosphere, Inc.
Lot Codes / Batch Numbers
Lot Numbers 121907002B, 010708002A, 012108002A, 012108002C, 012208002C, 012408002B, 012808002A, and 020608002A
Products Sold
Lot Numbers 121907002B, 010708002A, 012108002A, 012108002C, 012208002C, 012408002B, 012808002A, and 020608002A
Nanosphere, Inc. is recalling Warfarin Metabolism Nucleic Acid Test Cartridge; Part Number: 20-006-002; an in vitro diagnostic dru due to 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 heterozyg. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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).
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026