BEUDAMED
    FDA Recall Open, Classified

    Biofire Spotfire Respiratory/Sore Throat Panel REF: 423485

    Recall: Z-2081-2026 · Initiated April 1, 2026

    Recall

    Recall Number
    Z-2081-2026
    Event Number
    98719
    Firm
    BioFire Diagnostics, LLC
    FEI Number
    3002773840
    Product Code
    QOF
    Status
    Open, Classified
    Root Cause
    Under Investigation by firm
    Initiated
    April 1, 2026
    Posted
    May 6, 2026
    Address
    515 S Colorow Dr, Salt Lake City, UT, 84108-1248

    Description

    Biofire Spotfire Respiratory/Sore Throat Panel REF: 423485

    Reason

    Respiratory/sore throat panel test may result in false negative results and control failures.

    Action

    On April 1, 2026, Biomerieux, issued a "Urgent Medical Device Recall" via E-Mail. Biomerieux ask consignees to take the following actions: In this context, we request that you take the following actions: " Examine your inventory for the lot identified in this recall notice. "Discontinue use and discard any remaining product from this lot in your possession. "Please confirm the quantity of kits that have been destroyed, previously used, or returned on the attached Acknowledgement of Receipt Form. "If you have further distributed this product, please identify any recipients and notify them at once. " Please complete the accompanying Acknowledgement of Receipt Form and return to bioMrieux.

    Distribution

    US Nationwide distribution in the states of MS, TX MN, VA.

    Quantity

    2400 pouches