BEUDAMED
    FDA Enforcement Class II Terminated

    Microbiologics QC Sets and Panels: Helix Elite. Extended Enteric Bacterial Verification Panel (Inactivated Pellet) includes 21 pellets each comprised of the following 8 organisms: 1. S. Typhimurium derived from NCTC 74, 2. S. sonnei derived from NCTC 12984, 3. E. coli derived from CDC 2010C-3114 (STEC), 4. C. jejuni derived from NCTC 11322, 5. P. shigelloides derived from NCTC 10363, 6. Y. enterocolitica derived from NCTC 11174, 7. E. coli derived from NCTC 11602 (ETEC), 8. V. parahaemolyticus derived from NCTC 13209

    Recall: Z-0697-2022 · Reported March 9, 2022

    Enforcement

    Recall Number
    Z-0697-2022
    Event ID
    89446
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Microbiologics Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 9, 2022
    Initiation Date
    June 6, 2017
    Classification Date
    March 1, 2022
    Termination Date
    January 17, 2023
    Address
    200 Cooper Ave N, Saint Cloud, MN, 56303-4440, United States

    Description

    Microbiologics QC Sets and Panels: Helix Elite. Extended Enteric Bacterial Verification Panel (Inactivated Pellet) includes 21 pellets each comprised of the following 8 organisms: 1. S. Typhimurium derived from NCTC 74, 2. S. sonnei derived from NCTC 12984, 3. E. coli derived from CDC 2010C-3114 (STEC), 4. C. jejuni derived from NCTC 11322, 5. P. shigelloides derived from NCTC 10363, 6. Y. enterocolitica derived from NCTC 11174, 7. E. coli derived from NCTC 11602 (ETEC), 8. V. parahaemolyticus derived from NCTC 13209

    Reason

    Real-time shelf life testing failed at 24 months

    Code Info

    Catalog Number: 8191, Lot Number: 8191-01, UDI: 70845357041240

    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

    8 units