BEUDAMED
    FDA Recall Open, Classified

    COVID Test Kit Nonsterile

    Recall: Z-0071-2023 · Initiated August 12, 2022

    Recall

    Recall Number
    Z-0071-2023
    Event Number
    90800
    Firm
    American Contract Systems, Inc.
    FEI Number
    3008908305
    Product Code
    JSM
    Status
    Open, Classified
    Root Cause
    No Marketing Application
    Initiated
    August 12, 2022
    Posted
    October 8, 2022
    Address
    4801 W 81st St, Bloomington, MN, 55437-1111

    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.

    Action

    A customer letter dated 08/12/2022 was sent on or around 08/15/2022 to the single impacted consignee. The customer is instructed that the product cannot be used in association with SARS-CoV-2 or COVID-19 testing but instead only for general use of specimen collection. The product is to be relabeled in accordance with the recall communication letter. A Field Action Response Form is to be completed and returned to [email protected]. A second customer letter dated September 8, 2022 was sent on or around the same day to notify the consignee that 2 lots listed in this event cannot be relabeled, as they are subject to destruction from a previous recall event. Those two lots are Product #AHCV18A, lots 980221 and 974221. The consignee is requested to confirm destruction of the lots.

    Distribution

    Distribution to one customer in PA only

    Quantity

    39,575 kits