BEUDAMED
    FDA Recall Terminated

    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: Z-1383-2008 · Initiated February 25, 2008

    Recall

    Recall Number
    Z-1383-2008
    Event Number
    46882
    Firm
    Nanosphere, Inc.
    FEI Number
    3006028115
    Product Code
    ODW
    Status
    Terminated
    Root Cause
    Other
    Initiated
    February 25, 2008
    Posted
    March 31, 2008
    Terminated
    May 17, 2010
    Address
    4088 Commercial Ave, Northbrook, IL, 60062-1829

    Description

    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

    Reason

    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).

    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.

    Distribution

    Nationwide; USA including states of Kentucky, Michigan, Tennessee, Texas, Louisiana, Connecticut, Illinois, and California.

    Quantity

    624 units