BEUDAMED
    FDA Recall Open, Classified

    Helix Elite" Inactivated Standard: Inactivated SARS-CoV-2 Whole Virus (Pellet), Multi-analyte, unassayed quality control material, Catalog Number HE0065N

    Recall: Z-1371-2025 · Initiated February 20, 2025

    Recall

    Recall Number
    Z-1371-2025
    Event Number
    96382
    Firm
    Microbiologics Inc
    FEI Number
    2150138
    Product Code
    OHQ
    Status
    Open, Classified
    Root Cause
    Process control
    Initiated
    February 20, 2025
    Posted
    March 14, 2025
    Address
    200 Cooper Ave N, Saint Cloud, MN, 56303-4440

    Description

    Helix Elite" Inactivated Standard: Inactivated SARS-CoV-2 Whole Virus (Pellet), Multi-analyte, unassayed quality control material, Catalog Number HE0065N

    Reason

    The A549 human cell target (human cells for sample adequacy control) may give a late Ct value.

    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

    US Nationwide distribution in the states of TX. UK.

    Quantity

    6 units