BEUDAMED
    FDA Enforcement Class I Ongoing

    HXBL/WETEX/Genesis Biomedical Viral Transport Container, Model No. HX-K59-1

    Recall: Z-1399-2022 · Reported August 17, 2022

    Enforcement

    Recall Number
    Z-1399-2022
    Event ID
    90602
    Classification
    Class I
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Haimen Shengbang Laboratory Equipment Co. Ltd.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    August 17, 2022
    Initiation Date
    July 12, 2022
    Classification Date
    August 8, 2022
    Address
    D, Sanhe, No. 50 Xue Qian Road; Sanhezhen Haimen, Nantong, N/A, China

    Description

    HXBL/WETEX/Genesis Biomedical Viral Transport Container, Model No. HX-K59-1

    Reason

    Distributed VTM outside of VTM Guidance and without clearance.

    Code Info

    No UDI. All lots distributed in the US.

    Distribution

    Worldwide distribution - US Nationwide distribution in the states of CA, FL, IL & NY. The country of China.

    Quantity

    3,950,000 total units