BEUDAMED
    FDA Enforcement Class I Ongoing

    Dewei DNA/RNA Preservation Kit, Catalog number DW-80005-1B

    Recall: Z-0323-2023 · Reported December 14, 2022

    Enforcement

    Recall Number
    Z-0323-2023
    Event ID
    91137
    Classification
    Class I
    Status
    Ongoing
    Product Type
    Devices
    Firm
    DEWEI MEDICAL EQUIPMENT CO LTD
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Other
    Report Date
    December 14, 2022
    Initiation Date
    August 9, 2022
    Classification Date
    December 7, 2022
    Address
    5 Th Floor, No.4 Building,Shiyou Industrial Park, Jun'An,Shunde, Foshan, N/A, N/A, China

    Description

    Dewei DNA/RNA Preservation Kit, Catalog number DW-80005-1B

    Reason

    Products were distributed in the United States without FDA authorization or clearance.

    Code Info

    LOT / EXP DW200628 27-Jun-21 DW200520 19-May-21 DW200520 19-May-21 DW201202 01-Dec-21 DW201202 1-Dec-21 DW210103 2-Dec-22 DW210926 25-Sep-22

    Distribution

    US Distribution in states to: CA, FL, KY, and MI.

    Quantity

    1,348,000 (US)