BEUDAMED
    FDA Enforcement Class III Ongoing

    VerifyNow PRUTest Platelet Reactivity Test REF 85225 UDI-DI code: 10711234150078 The VerifyNow PRUTest is a whole blood test used in the laboratory or point of care setting to measure the level of platelet P2Y12 receptor blockade.

    Recall: Z-0500-2026 · Reported November 19, 2025

    Enforcement

    Recall Number
    Z-0500-2026
    Event ID
    97863
    Classification
    Class III
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Accriva Diagnostics, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    November 19, 2025
    Initiation Date
    October 21, 2025
    Classification Date
    November 13, 2025
    Address
    6260 Sequence Dr, San Diego, CA, 92121-4358, United States

    Description

    VerifyNow PRUTest Platelet Reactivity Test REF 85225 UDI-DI code: 10711234150078 The VerifyNow PRUTest is a whole blood test used in the laboratory or point of care setting to measure the level of platelet P2Y12 receptor blockade.

    Reason

    Due to an device without a premarket clearance being incorrectly package and distributed.

    Code Info

    Catalog Number: 85225 UDI-DI code: 10711234150078 Lot Number: WP1559-01

    Distribution

    Worldwide - U.S. Nationwide distribution in the states of AK, CA, FL, IA, IL, MD, MI, NY, SD, and TX. The countries of Hong Kong, Japan.

    Quantity

    125 boxes (3,125 tests)