BEUDAMED
    FDA Enforcement Class III Terminated

    BIOPHEN UFH Control Plasma

    Recall: Z-1743-2022 · Reported September 21, 2022

    Enforcement

    Recall Number
    Z-1743-2022
    Event ID
    90765
    Classification
    Class III
    Status
    Terminated
    Product Type
    Devices
    Firm
    Aniara Diagnostica LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    September 21, 2022
    Initiation Date
    June 28, 2022
    Classification Date
    September 15, 2022
    Termination Date
    April 18, 2024
    Address
    7768 Service Center Dr, West Chester, OH, 45069-2442, United States

    Description

    BIOPHEN UFH Control Plasma

    Reason

    Incorrect product labeling was included in the package.

    Code Info

    UDI-DI (GTIN): 03663537008290 Reference No.: 223101; Lot Code: FA2035

    Distribution

    Distribution in US - IL and MI

    Quantity

    13 units (1 unit is 1 box)