BEUDAMED
    FDA Recall Open, Classified

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

    Recall: Z-1399-2022 · Initiated July 12, 2022

    Recall

    Recall Number
    Z-1399-2022
    Event Number
    90602
    Firm
    Haimen Shengbang Laboratory Equipment Co. Ltd. D, Sanhe No. 50 Xue Qian Road; Sanhezhen Haimen Nantong China
    FEI Number
    3011676045
    Product Code
    QMC
    Status
    Open, Classified
    Root Cause
    No Marketing Application
    Initiated
    July 12, 2022

    Description

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

    Reason

    Distributed VTM outside of VTM Guidance and without clearance.

    Action

    The firm distributed a recall notification via email on 07/12/2022 dated 07/11/2022. This notification identifies the reason for recall to be that all vials of VTM distributed to the United States had not obtained 510K clearance and they weren't approved by FDA under the VTM Enforcement Policy. Customers are asked to identify any unused product and destroy it on-site. Additionally, testing institutions that have used product should evaluate previously obtained test results and evaluate the need to re-test patients. The firm has communicated they intend to apply to FDA for 510K clearance in the future for the recalled device. Customers with any questions are to conact Lei Fan at +86-18938033981 or [email protected].

    Distribution

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

    Quantity

    3,950,000 total units