BEUDAMED
    FDA Recall 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 · Initiated July 27, 2022

    Recall

    Recall Number
    Z-1740-2022
    Event Number
    90761
    Firm
    Microbiologics Inc
    FEI Number
    2150138
    Product Code
    OHQ
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    July 27, 2022
    Posted
    September 14, 2022
    Terminated
    August 2, 2024
    Address
    200 Cooper Ave N, Saint Cloud, MN, 56303-4440

    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

    Action

    Microbiologics initially contacted the consignee via email on 07/27/2022. A formal letter was provided via email on 08/15/2022. The notification instructed the consignee to review lab procedures to understand how the recall affects their usage, discard any units depending on the lab procedures, complete and return the response form, maintain the recall letter for record, and contact Microbiologics for replacement if needed.

    Distribution

    International distribution to the country of United Kingdom.

    Quantity

    2