BEUDAMED
    FDA Enforcement Class III Terminated

    Helix Elite Inactivated Standard, labeled as: a. Inactivated SARS-CoV-2 B.1.1.7 Whole Virus, REF HE0071N; b. Inactivated SARS-CoV-2 B.1.351 Whole Virus, REF HE0073N

    Recall: Z-1740-2022 · Reported September 21, 2022

    Enforcement

    Recall Number
    Z-1740-2022
    Event ID
    90761
    Classification
    Class III
    Status
    Terminated
    Product Type
    Devices
    Firm
    Microbiologics Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    September 21, 2022
    Initiation Date
    July 27, 2022
    Classification Date
    September 16, 2022
    Termination Date
    August 2, 2024
    Address
    200 Cooper Ave N, Saint Cloud, MN, 56303-4440, United States

    Description

    Helix Elite Inactivated Standard, labeled as: a. Inactivated SARS-CoV-2 B.1.1.7 Whole Virus, REF HE0071N; b. Inactivated SARS-CoV-2 B.1.351 Whole Virus, REF HE0073N

    Reason

    Product not registered for use in the UK

    Code Info

    a. UDI Number: 10845357043846, Lot Number: HE0071-01-1, Expiration Date: 12/31/2022. b. UDI Number: 10845357043945, Lot Number: HE0073-02-2, Expiration Date: 02/28/2023.

    Distribution

    International distribution to the country of United Kingdom.

    Quantity

    2