BEUDAMED
    FDA Enforcement Class III Terminated

    BIOPHEN UFH Control C1, REF 224101

    Recall: Z-1189-2019 · Reported April 24, 2019

    Enforcement

    Recall Number
    Z-1189-2019
    Event ID
    82468
    Classification
    Class III
    Status
    Terminated
    Product Type
    Devices
    Firm
    Aniara Diagnostica LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    April 24, 2019
    Initiation Date
    March 19, 2019
    Classification Date
    April 17, 2019
    Termination Date
    July 12, 2019
    Address
    7768 Service Center Dr, N/A, West Chester, OH, 45069-2442, United States

    Description

    BIOPHEN UFH Control C1, REF 224101

    Reason

    The manufacturer packaged incorrect versions of the Instructions for Use into specific lots for three device product codes.

    Code Info

    Lots F1700314P2, F1700314P3, F1700314P4, F1801638P1

    Distribution

    Distributed to accounts in MI and PA.

    Quantity

    41 units