BEUDAMED
    FDA Enforcement Class I Ongoing

    Jiangsu Well Biotech Co.,Ltd. AND SDI LABS COVID-19 Ag Rapid Test Device - Cat#: CO-02

    Recall: Z-0001-2023 · Reported October 19, 2022

    Enforcement

    Recall Number
    Z-0001-2023
    Event ID
    90773
    Classification
    Class I
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Jiangsu Well Biotech Co.,Ltd.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    October 19, 2022
    Initiation Date
    August 9, 2022
    Classification Date
    October 7, 2022
    Address
    No 9 Changyang Rd West, N/A, Changzhou, N/A, N/A, China

    Description

    Jiangsu Well Biotech Co.,Ltd. AND SDI LABS COVID-19 Ag Rapid Test Device - Cat#: CO-02

    Reason

    Distribution of COVID-19 Ag Rapid Test kits in the U.S. without an Emergency Use Authorization, or a Pre-Market Approval or Clearance.

    Code Info

    Catalog Number: CO-02 UDI-DI Code: No UDI Codes provided Lot Numbers: 202107192, 202108231, 202109231, 202111082, 202110111, 202201102,

    Distribution

    U.S.: CA (pending firm supplying additional distribution locations/consignee list). O.U.S.: N/A

    Quantity

    620,000 tests