BEUDAMED
    FDA Recall Terminated

    Helix Elite" Molecular Standards: Inactivated Standard. Inactivated Influenza A/B and Respiratory Syncytial Virus

    Recall: Z-0701-2022 · Initiated June 6, 2017

    Recall

    Recall Number
    Z-0701-2022
    Event Number
    89446
    Firm
    Microbiologics Inc
    FEI Number
    2150138
    Product Code
    OHQ
    Status
    Terminated
    Root Cause
    Process design
    Initiated
    June 6, 2017
    Terminated
    January 17, 2023
    Address
    200 Cooper Ave N, Saint Cloud, MN, 56303-4440

    Description

    Helix Elite" Molecular Standards: Inactivated Standard. Inactivated Influenza A/B and Respiratory Syncytial Virus

    Reason

    Real-time shelf life testing failed at 24 months

    Action

    Microbiologics notified customers on about 06/06/2017 via email containing a letter. The letters indicated the affected products and instructed customers to update their records with the corrected expiration date, which was provided for each affected lot.

    Distribution

    Worldwide distribution - US Nationwide distribution in the states of AK, CA, DC, FL, IA, ID, KS, LA, MD, MN, MO, NE, NH, NJ, NY, OH, OK, PA, SC, TX, VA, WA, WV and the countries of Australia, Belgium, Canada, India, United Kingdom.

    Quantity

    1 unit