BEUDAMED
    FDA Enforcement Class II Terminated

    Disposable Sampling Tube, REF VSM01, Contents: Transport Media - 50, Nasal Swab - 50, Package Insert - 1, IVD, CE

    Recall: Z-1420-2021 · Reported April 21, 2021

    Enforcement

    Recall Number
    Z-1420-2021
    Event ID
    87595
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Krishe Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 21, 2021
    Initiation Date
    March 11, 2021
    Classification Date
    April 13, 2021
    Termination Date
    November 16, 2022
    Address
    8105 Razor Blvd Ste 213, N/A, Plano, TX, 75024, United States

    Description

    Disposable Sampling Tube, REF VSM01, Contents: Transport Media - 50, Nasal Swab - 50, Package Insert - 1, IVD, CE

    Reason

    Verification and validation of the virus transport medium tubes was not provided to FDA prior to sale and marketing

    Code Info

    All Lots

    Distribution

    US: LA, TX, FL, GA

    Quantity

    1,700,000 units