BEUDAMED
    FDA Recall Terminated

    Verigene CYP2C19 Nucleic Acid Test (CYP2C19 Test). Each CYP2C19 kit consists of 20 Verigene CYP2C19 Nucleic Acid Test Cartridges and 20 Verigene CYP2C19 Nucleic Acid Extraction Trays (with Tip Holder Assemblies). Clinical laboratory test.

    Recall: Z-2559-2014 · Initiated March 18, 2014

    Recall

    Recall Number
    Z-2559-2014
    Event Number
    68710
    Firm
    Nanosphere, Inc.
    FEI Number
    3006028115
    Product Code
    NTI
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    March 18, 2014
    Posted
    August 28, 2014
    Terminated
    July 2, 2015
    Address
    4088 Commercial Ave, Northbrook, IL, 60062-1829

    Description

    Verigene CYP2C19 Nucleic Acid Test (CYP2C19 Test). Each CYP2C19 kit consists of 20 Verigene CYP2C19 Nucleic Acid Test Cartridges and 20 Verigene CYP2C19 Nucleic Acid Extraction Trays (with Tip Holder Assemblies). Clinical laboratory test.

    Reason

    Nanosphere has recieved reports related to an unacceptable increase in initial no-call rate when performing the Verigene CYP2C19 Nucleic Acid Test (2C19), which has been confirmed through internal testing.

    Action

    Nanosphere sent an Field Notification Letter dated March 18, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The letters included instructions for customers to: 1) discontinue use of the affected products, 2) discard the affected product, and 3) complete and return the attached for to obtain free-of-charge replacement kits. Customers with any questions about this recall should contact their Nanosphere technical support representative at 1 888 837-4436. .

    Distribution

    Worldwide Distribution - US including the states of AL, CA, MD, ND, NJ, OK and TX., and internationally to Bulgaria, China and New Zealand.

    Quantity

    78 kits