BEUDAMED
    FDA Recall Open, Classified

    BioFire Respiratory Panel 2.1 plus Kit, REF: 423740, For Filmarray systems

    Recall: Z-1877-2025 · Initiated April 30, 2025

    Recall

    Recall Number
    Z-1877-2025
    Event Number
    96835
    Firm
    BioFire Diagnostics, LLC
    FEI Number
    3002773840
    Product Code
    OCC
    Status
    Open, Classified
    Root Cause
    Under Investigation by firm
    Initiated
    April 30, 2025
    Posted
    May 29, 2025
    Address
    515 S Colorow Dr, Salt Lake City, UT, 84108-1248

    Description

    BioFire Respiratory Panel 2.1 plus Kit, REF: 423740, For Filmarray systems

    Reason

    Due to manufacturing error, respiratory panel may result in elevated control failures and/or false negative results.

    Action

    On April 30, 2025, Biomerieux issued a "Urgent Field Safety Notice" to affected consignees via email. Biomerieux asked consignees to take the following actions: 1. Immediately examine your inventory for the lot identified in this field safety notice. 2. Discontinue use and discard any remaining product from this lot in your possession. 3. As previously confirmed discontinued use of product, please confirm the amount of kits destroyed on the attached Acknowledgement of Receipt Form. 4. If you have further distributed this product, please identify any recipients and notify them at once. 5. Please complete the accompanying Acknowledgement of Receipt Form and return to bioMrieux so that bioMrieux may acknowledge your receipt of this notification.

    Distribution

    International distribution in the country of Singapore.

    Quantity

    30 kits