BEUDAMED
    FDA Recall Open, Classified

    Microbiologics Multi-Strain Human Papillomavirus (HPV) Control Panel (Inactivated Pellet), REF 8234; in-vitro diagnostic test

    Recall: Z-1163-2025 · Initiated January 20, 2025

    Recall

    Recall Number
    Z-1163-2025
    Event Number
    96166
    Firm
    Microbiologics Inc
    FEI Number
    2150138
    Product Code
    OHQ
    Status
    Open, Classified
    Root Cause
    Under Investigation by firm
    Initiated
    January 20, 2025
    Posted
    February 12, 2025
    Address
    200 Cooper Ave N, Saint Cloud, MN, 56303-4440

    Description

    Microbiologics Multi-Strain Human Papillomavirus (HPV) Control Panel (Inactivated Pellet), REF 8234; 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.

    Action

    Microbiologics issued and Urgent Medical Device Recall notice to its consignees on 01/20/2025 via email. The notice explained the issue and requested the following actions be taken: INSTRUCTIONS: 1. REVIEW lab procedures to understand how this information affects your usage 2. DISCARD affected product. 3. COMPLETE the response form provided. 4. RETURN the response form to [email protected] 5. KEEP this letter for your records. 6. NOTIFY other facilities or customers to whom the product may have been distributed or transferred. 7. CONTACT Microbiologics if a replacement kit is needed. Please contact our Recall Support team at 320.229.7080 or [email protected] with questions or concerns.

    Distribution

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

    Quantity

    16 units