BEUDAMED
    FDA Recall Open, Classified

    FILMARRAY Gastrointestinal (GI) Panel (Part No.: RFIT-ASY-0104 & RFIT-ASY-0116) Pouch Module Software

    Recall: Z-2588-2023 · Initiated April 25, 2023

    Recall

    Recall Number
    Z-2588-2023
    Event Number
    92885
    Firm
    BioFire Diagnostics, LLC
    FEI Number
    3002773840
    Product Code
    PCH
    Status
    Open, Classified
    Root Cause
    Software design
    Initiated
    April 25, 2023
    Posted
    September 30, 2024
    Address
    515 S Colorow Dr, Salt Lake City, UT, 84108-1248

    Description

    FILMARRAY Gastrointestinal (GI) Panel (Part No.: RFIT-ASY-0104 & RFIT-ASY-0116) Pouch Module Software

    Reason

    The firm has identified an increased risk of obtaining false positive Cryptosporidium results from customers using the BIOFIRE FILMARRAY Gastrointestinal (GI) Panel

    Action

    On 4/25/23 correction notices were mailed to customers who were told to update the GI pouch module software. Instructions for installation can be downloaded here: https://www.biofiredx.com/e-labeling/ITIFA20GI21. This technical note and download cannot be opened via Firefox browser; please use a different browser. Once the pouch module software has been updated, complete and return the webform located at: https://www.biofiredx.com/gisoftware-5747 or return the acknowledgement form via email to [email protected] Questions or concerns can be directed to Technical Support at [email protected] or via telephone by dialing 1.800.735.6544 and selecting option 5.

    Distribution

    US:DE, AK, AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VI, VT, WA, WI, WV, WY. OUS: AD, AE, AI, AR, AT, AU, BD, BE, BF, BG, BH, BR, CA, CH, CL, CN, CO, CY, CZ, DE, DK, DZ, EE, ES, FI, FR, GA, GB, GE, GH, GM, GR, GU, HK, HU, IC, ID, IE, IL, IN, IQ, IT, JP, KE, KR, KW, LV, MO, MX, MY, NL, NO, NP, NZ, PG, PH, PL, PT, QA, RS, SA, SE, SG, SI, TH, TN, TR, TW, VN, ZA, ZW

    Quantity

    61,069