BEUDAMED
    FDA Enforcement Class II Ongoing

    QUCARE Total Cholesterol in vitro diagnostic test REF: 6407

    Recall: Z-2085-2026 · Reported May 13, 2026

    Enforcement

    Recall Number
    Z-2085-2026
    Event ID
    98739
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    DFI Co., Ltd.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    May 13, 2026
    Initiation Date
    April 2, 2026
    Classification Date
    May 6, 2026
    Address
    388-25 Gomo-Ro, Jillye-Myeon, Gimhae, N/A, Korea (the Republic of)

    Description

    QUCARE Total Cholesterol in vitro diagnostic test REF: 6407

    Reason

    The devices were distributed without required FDA premarket clearance or approval.

    Code Info

    UDI: 08806141303060/ Lot: BS032501, BS042502, BS062501, BS062502, BS082501

    Distribution

    Worldwide - US Nationwide distribution in the states of FL, PA and the country of England.

    Quantity

    6398 units