BEUDAMED
    FDA Recall Open, Classified

    BIOFIRE FILMARRAY Pneumonia Panel, REF: RFIT-ASY-0144

    Recall: Z-2682-2024 · Initiated June 10, 2024

    Recall

    Recall Number
    Z-2682-2024
    Event Number
    94942
    Firm
    BioFire Diagnostics, LLC
    FEI Number
    3002773840
    Product Code
    QDS
    Status
    Open, Classified
    Root Cause
    Nonconforming Material/Component
    Initiated
    June 10, 2024
    Posted
    August 16, 2024
    Address
    515 S Colorow Dr, Salt Lake City, UT, 84108-1248

    Description

    BIOFIRE FILMARRAY Pneumonia Panel, REF: RFIT-ASY-0144

    Reason

    Pneumonia panels have an increased risk of control failures due to an issue in the manufacturing process, which could lead to delayed results for the customer.

    Action

    On 6/10/24, field safety notices were sent to laboratory managers who were informed of the following: Discontinue use and discard any remaining product in your possession. If you have further distributed this product, please identify any recipients, and notify them at once. Complete and return the Acknowledgement of Receipt Form and return via email to [email protected] If you have questions, please contact your firm's local US Commercial Operations. at (800) 682-2666. For non-urgent inquiries, please contact the Technical Support Center by email at [email protected]. The anticipated turnaround time for email inquiries is 24 - 48 hours during normal business hours.

    Distribution

    Worldwide - US Nationwide distribution in the states of WV, IN, AL and the countries of France, Italia, Spain, Greece, Japan Ltd, Singapore, Chile, Taiwan, Israel, Romania, Ecuador, Serbia.

    Quantity

    58