BEUDAMED
    FDA Recall Open, Classified

    FilmArray Pneumonia Panel (Pneumo), REF: FIT-ASY-0144, CED 2797, IVD, Rx Only (30 test kit)

    Recall: Z-0994-2024 · Initiated December 14, 2023

    Recall

    Recall Number
    Z-0994-2024
    Event Number
    93592
    Firm
    BioFire Diagnostics, LLC
    FEI Number
    3002773840
    Product Code
    QBH
    Status
    Open, Classified
    Root Cause
    Under Investigation by firm
    Initiated
    December 14, 2023
    Posted
    February 6, 2024
    Address
    515 S Colorow Dr, Salt Lake City, UT, 84108-1248

    Description

    FilmArray Pneumonia Panel (Pneumo), REF: FIT-ASY-0144, CED 2797, IVD, Rx Only (30 test kit)

    Reason

    Their is a potential for false positive results when using Pneumonia panel.

    Action

    On December 14, 2023, Biomerieux, issued a "Urgent Medical Recall" to affected consignees via: FedEx . Biomerieux asked consignees to take the following actions: 1. Distribute this information to all appropriate personnel in your laboratory, retain a copy in your files, and forward this information to all parties that may use this product, including others to whom you may have transferred our product. 2. Use another method to confirm positive results for seasonal Coronavirus from the BIOFIRE Pneumonia Panel or BIOFIRE Pneumonia Panel plus prior to reporting the result (e.g., consider results from testing a nasopharyngeal swab with a different BIOFIRE respiratory panel such as the BIOFIRE Respiratory Panel 2.1). Alternatively, the BIOFIRE Pneumonia Panel or BIOFIRE Pneumonia Panel plus seasonal Coronavirus positive result should not be reported. 3. Complete the Acknowledgement Form in Attachment A (on the following page) and return it to bioMrieux to confirm receipt of this notice. It is important that you return the acknowledgement form to bioMrieux even if you determine that this urgent product correction notice does not impact your facility.

    Distribution

    Worldwide - US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NJ, NM, NV, NY, OH, OK, OR, PA, PR, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY and the countries of Argentina, Bolivia, Brazil, Chili, China, Colombia, Costa Rica, Dominican Republic, Ecuador, Guatemala, Hong Kong, Honduras, Japan, South Korea, Mexico, Nicaragua, Panama, Peru, Philippines, Paraguay, Singapore, El Salvador, Thailand, Taiwan, Uruguay, Venezuela.

    Quantity

    274,290 units