BEUDAMED
    FDA Enforcement Class II Ongoing

    COVID Test Kit Nonsterile

    Recall: Z-0071-2023 · Reported October 19, 2022

    Enforcement

    Recall Number
    Z-0071-2023
    Event ID
    90800
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    American Contract Systems, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    October 19, 2022
    Initiation Date
    August 12, 2022
    Classification Date
    October 8, 2022
    Address
    4801 W 81st St, N/A, Bloomington, MN, 55437-1111, United States

    Description

    COVID Test Kit Nonsterile

    Reason

    Kit incorrectly labeled for use with COVID testing and should not be used with any SARS-Co-V2 device.

    Code Info

    1) UDI-DI: Product Code: AHCV18A, Lots 980221 (exp. 01/20/2023) and 974221 (exp. 01/25/2023) 2) UDI-DI: Product Code: AHCV18B, Lots 868221 (exp. 05/31/2023), 842221 (exp. 05/31/2023)

    Distribution

    Distribution to one customer in PA only

    Quantity

    39,575 kits