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
FDA Recall Z-1383-2008 · Posted 2008-03-31
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Recalling FirmNanosphere, Inc.
Recall StatusTerminated
Product CodeODW
Date Initiated2008-02-25
Date Terminated2010-05-17
Product Quantity624 units
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).
Firm 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.
Root Cause
Other
Distribution Pattern
Nationwide; USA including states of Kentucky, Michigan, Tennessee, Texas, Louisiana, Connecticut, Illinois, and California.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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