BEUDAMED
    FDA Enforcement Class II Ongoing

    Vivoo Protein Test

    Recall: Z-1265-2026 · Reported February 11, 2026

    Enforcement

    Recall Number
    Z-1265-2026
    Event ID
    97801
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Changchun Wancheng Bio-Electron Co., Ltd.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    February 11, 2026
    Initiation Date
    November 22, 2025
    Classification Date
    February 4, 2026
    Address
    2336, Tianwei Road, Beihu Science and Technology Development Zone, Changchun, N/A, N/A, China

    Description

    Vivoo Protein Test

    Reason

    Test strips and other tests including for near-patient testing, that require a 510(k) were distributed before they could be legally marketed to U.S. customers; devices may cause false or inaccurate diagnostic result by lay person and lead to inappropriate medical intervention.

    Code Info

    Name/Lot(Expiration): Vivoo Protein Test/2024013122(01/30/2026)

    Distribution

    US Nationwide distribution in the states of TX, GA, CA.

    Quantity

    500