BEUDAMED
    FDA Enforcement Class II Ongoing

    Microbiologics Multi-Strain Human Papillomavirus (HPV) Verification Panel (Inactivated Pellet), REF 8235; in-vitro diagnostic test

    Recall: Z-1164-2025 · Reported February 19, 2025

    Enforcement

    Recall Number
    Z-1164-2025
    Event ID
    96166
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Microbiologics Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    February 19, 2025
    Initiation Date
    January 20, 2025
    Classification Date
    February 12, 2025
    Address
    200 Cooper Ave N, Saint Cloud, MN, 56303-4440, United States

    Description

    Microbiologics Multi-Strain Human Papillomavirus (HPV) Verification Panel (Inactivated Pellet), REF 8235; in-vitro diagnostic test

    Reason

    Internal quality control procedures were not followed correctly for the testing/release of three lots of 8234/8235. This resulted in the release of products that should have failed and been discarded. The concentration of one target (HPV 16 L1) was low enough to cause QC failures, no detection, or invalid results on some instruments and assays.

    Code Info

    UDI/DI 70845357043077, Lot Numbers: 8235-32, 8235-33

    Distribution

    Worldwide distribution - US Nationwide and the countries of Netherlands, Sweden, UK, France, Australia, New Zealand.

    Quantity

    27 units