BEUDAMED
    FDA Enforcement Class I Ongoing

    Nasopharyngeal sample collection tray for COVID-19 testing, labeled as COVID TEST KIT NONSTERILE 184312, AHCV18A

    Recall: Z-1277-2022 · Reported July 13, 2022

    Enforcement

    Recall Number
    Z-1277-2022
    Event ID
    90324
    Classification
    Class I
    Status
    Ongoing
    Product Type
    Devices
    Firm
    American Contract Systems, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 13, 2022
    Initiation Date
    May 2, 2022
    Classification Date
    July 1, 2022
    Address
    2610 Ne Industrial Dr Ste 220, N/A, Kansas City, MO, 64117-2648, United States

    Description

    Nasopharyngeal sample collection tray for COVID-19 testing, labeled as COVID TEST KIT NONSTERILE 184312, AHCV18A

    Reason

    Affected products were assembled off-site by individuals who may not have been properly trained.

    Code Info

    UDI-DI: 00191072121233 Lots: 721211, 672211, 657211, 994221, 980221, 974221

    Distribution

    US distribution in the state of Minnesota.

    Quantity

    274,400 kits total