BEUDAMED
    FDA Enforcement Class II Terminated

    VerifyNow System, part #85005-6H Product Usage: The VerifyNow P2Y12 assay device is a whole blood assay used in the laboratory or point of care setting to measure the level of platelet P2Y12 receptor blockade. The VerifyNow Systems intended for use with human whole blood and verify now test devices. The system should be operated by healthcare professionals trained on use of the system and in accordance with institution and policies and procedures. Accumetrics respresentatives will assist your institution in the installation of the system and operations of the operator.

    Recall: Z-1854-2012 · Reported June 27, 2012

    Enforcement

    Recall Number
    Z-1854-2012
    Event ID
    61761
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Accumetrics Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    June 27, 2012
    Initiation Date
    February 6, 2012
    Classification Date
    June 21, 2012
    Termination Date
    November 27, 2012
    Address
    3985 Sorrento Valley Blvd Ste B, N/A, San Diego, CA, 92121-1497, United States

    Description

    VerifyNow System, part #85005-6H Product Usage: The VerifyNow P2Y12 assay device is a whole blood assay used in the laboratory or point of care setting to measure the level of platelet P2Y12 receptor blockade. The VerifyNow Systems intended for use with human whole blood and verify now test devices. The system should be operated by healthcare professionals trained on use of the system and in accordance with institution and policies and procedures. Accumetrics respresentatives will assist your institution in the installation of the system and operations of the operator.

    Reason

    The recall was initiated by Accumetrics because of a field correction to the VerifyNow System; specifically the results reported when running the VerifyNow P2Y12 Test. Currently the VerifyNow P2Y12 Test reports three values: PRU, BASE and % Inhibition. The change implemented is the elimination of the BASE and % Inhibition results. There will be no change to the reporting of the PRU result whic

    Code Info

    Not available

    Distribution

    US Nationwide Distribution

    Quantity

    1,167 units total