BEUDAMED
    FDA Enforcement Class II Terminated

    Universal Sexual Health Testing Kit

    Recall: Z-0350-2020 · Reported November 20, 2019

    Enforcement

    Recall Number
    Z-0350-2020
    Event ID
    83709
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Privapath Diagnostics Ltd
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Telephone
    Report Date
    November 20, 2019
    Initiation Date
    July 1, 2019
    Classification Date
    November 8, 2019
    Termination Date
    November 23, 2020
    Address
    Unit A10 Block A, Calmount Park; Calmount Avenue, Dublin 12, N/A, N/A, Ireland

    Description

    Universal Sexual Health Testing Kit

    Reason

    A supplier informed PrivaPath Diagnostics that there is a potential for damaged tubes which could result in blood exposure or erroneous results due to an inappropriate blood-to-additive ratio.

    Code Info

    lot numbers: 1189 1094 144 226 82

    Distribution

    Nationwide

    Quantity

    N/A