BEUDAMED
    FDA Enforcement Class II Ongoing

    VerifyNow P2Y12 Platelet Reactivity Test, REF: 85064

    Recall: Z-0961-2025 · Reported January 22, 2025

    Enforcement

    Recall Number
    Z-0961-2025
    Event ID
    96011
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Accriva Diagnostics, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    January 22, 2025
    Initiation Date
    December 2, 2024
    Classification Date
    January 16, 2025
    Address
    6260 Sequence Dr, San Diego, CA, 92121-4358, United States

    Description

    VerifyNow P2Y12 Platelet Reactivity Test, REF: 85064

    Reason

    Platelet Reactivity Test distributed without appropriate US-FDA market clearance; if used healthcare personnel could use the baseline PRUTest measurement prior to initiating drug therapy, and then use the percent inhibition formula in the notice to manually calculate the percentage of platelet aggregation inhibition for a given patient receiving drug treatment with P2Y12 receptor inhibitor.

    Code Info

    UDI-DI: 10711234150054. Lot: WL1145. Expiration: 2025-10-18

    Distribution

    US Nationwide distribution in the state of VA.

    Quantity

    25