BEUDAMED
    FDA Enforcement Class II Ongoing

    ORAcollect RNA: ORE-100

    Recall: Z-0982-2022 · Reported April 27, 2022

    Enforcement

    Recall Number
    Z-0982-2022
    Event ID
    89831
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    DNA Genotek Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    April 27, 2022
    Initiation Date
    February 18, 2022
    Classification Date
    April 21, 2022
    Address
    3000-500 Palladium Dr, Kanata, N/A, Canada

    Description

    ORAcollect RNA: ORE-100

    Reason

    Evaporation of stabilizing liquid reducing shelf life.

    Code Info

    Lot: YJ530

    Distribution

    Worldwide distribution - US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, ND, NE, NH, NV, NY, OH, OK, OR, PA, PR, SC, TN, TX, UT, VA, WI and the countries of Australia Belgium, Brazil, Canada, Chile, China, Croatia Denmark, Finland, Germany, Great Britain, Italy, Japan, Netherlands, South Africa, and Thailand.

    Quantity

    17,080 (US: 14, 17,066)