BEUDAMED
    FDA Enforcement Class I Ongoing

    Ellume COVID-19 Home Test

    Recall: Z-0183-2022 · Reported November 17, 2021

    Enforcement

    Recall Number
    Z-0183-2022
    Event ID
    88801
    Classification
    Class I
    Status
    Ongoing
    Product Type
    Devices
    Firm
    ELLUME LTD
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    November 17, 2021
    Initiation Date
    October 1, 2021
    Classification Date
    November 10, 2021
    Address
    57 Didsbury St, N/A, East Brisbane, N/A, N/A, Australia

    Description

    Ellume COVID-19 Home Test

    Reason

    Due to a higher rate of false positive test results.

    Code Info

    Catalogue number I-SRS-C-01 Master Lot Numbers: 21047-4; 21047-5; 21089-1; 21117-1; PF06Z-H; 21099-1; 21124-1; 21125-1; PF03X-H; PF057-H; PF05W-H; PF069-H; PF06E-H; PF06N-H; PF06Z-H; PG080-H; PG08H-H; PH08X-H;

    Distribution

    U.S.: MN, NY, PA, RI, UT, WA. O.U.S.: Not provided

    Quantity

    427,994 kits