BEUDAMED
    FDA Recall Terminated

    FilmArray Pneumonia Panel (Penumo) REF RFIT-ASY-0144

    Recall: Z-1944-2021 · Initiated April 16, 2021

    Recall

    Recall Number
    Z-1944-2021
    Event Number
    87936
    Firm
    BioFire Diagnostics, LLC
    FEI Number
    3002773840
    Product Code
    QBH
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    April 16, 2021
    Terminated
    April 2, 2024
    Address
    515 S Colorow Dr, Salt Lake City, UT, 84108-1248

    Description

    FilmArray Pneumonia Panel (Penumo) REF RFIT-ASY-0144

    Reason

    Elevated rates of false positive/false negative and control failures while using the Pneumonia Panel, due to issues identified in the manufacturing process.

    Action

    On 04/16/2021, the firm sent an "URGENT: MEDICAL DEVICE RECALL" Notification Letter via email informing its customers of an issue identified in the manufacturing process which might contribute to elevated rates of false positive/false negative results and control failures while using the pneumonia panel. Customer are instructed to: 1) Immediately examine their inventory for product identified in this recall. 2) Discontinue use and discard any remaining product in their possession that is subject to this recall. The Recalling Firm will replace the product at no charge in accordance with its standard limited warranty. 3) Confirm the amount of pouches scrapped (if any) on the attached Acknowledgement of Receipt Form. 4) If the affected products have been further distributed, customers are to identify any recipients and notify them at once of this product recall. 5) Complete the accompanying Field Action Acknowledgment of Receipt Form and return to Recalling Firm so that it may acknowledge their receipt of this notification. For questions or concerns contact Customer Support Department at [email protected] or via telephone 1-800-735-6544, option 5 for Product Technical Support.

    Distribution

    U.S. Nationwide distribution in the states of MN and OK. O.U.S.: None

    Quantity

    9 kits (U.S. only)