BEUDAMED
    FDA Recall Open, Classified

    Helix Elite Inactivated Standard: Inactivated Influenza A/B and Respiratory Syncytial Virus, Multi-analyte, unassayed quality control material, Catalog Number HE0044N

    Recall: Z-1454-2025 · Initiated February 20, 2025

    Recall

    Recall Number
    Z-1454-2025
    Event Number
    96381
    Firm
    Microbiologics Inc
    FEI Number
    2150138
    Product Code
    OHQ
    Status
    Open, Classified
    Root Cause
    Nonconforming Material/Component
    Initiated
    February 20, 2025
    Posted
    March 25, 2025
    Address
    200 Cooper Ave N, Saint Cloud, MN, 56303-4440

    Description

    Helix Elite Inactivated Standard: Inactivated Influenza A/B and Respiratory Syncytial Virus, Multi-analyte, unassayed quality control material, Catalog Number HE0044N

    Reason

    The RSV target may give a late Ct value and could potentially not pass QC.

    Action

    An Urgent Medical Device Recall notification letter dated 2/20/25 was sent to customers. 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. Microbiologics is dedicated to ensuring the success of your quality control processes. Please contact our Recall Support team at 320.229.7080 or [email protected] with questions or concerns. Collect calls may be made.

    Distribution

    Worldwide - US Nationwide distribution in the states of KY, MT, NJ, NY, WI and the countries of Ireland, Germany, UK.

    Quantity

    28 units