BEUDAMED
    FDA Enforcement Class II Ongoing

    BIOFIRE FILMARRAY Gastrointestinal (GI) Panel REF RFIT-ASY-0116 (30 test kit) BIOFIRE FILMARRAY Gastrointestinal (GI) Panel REF RFIT-ASY-0104 (6 kit test) The BIOFIRE FILMARRAY Gastrointestinal (GI) Panel is a qualitative multiplexed nucleic acid-based in vitro diagnostic test intended for use with BIOFIRE¿ FILMARRAY¿ Systems. The BIOFIRE GI Panel is capable of the simultaneous detection and identification of nucleic acids from multiple bacteria, viruses, and parasites directly from stool samples in Cary Blair transport media obtained from individuals with signs and/or symptoms of gastrointestinal infection.

    Recall: Z-2514-2024 · Reported August 14, 2024

    Enforcement

    Recall Number
    Z-2514-2024
    Event ID
    94992
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    BioFire Diagnostics, LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    August 14, 2024
    Initiation Date
    May 16, 2024
    Classification Date
    August 6, 2024
    Address
    515 S Colorow Dr, Salt Lake City, UT, 84108-1248, United States

    Description

    BIOFIRE FILMARRAY Gastrointestinal (GI) Panel REF RFIT-ASY-0116 (30 test kit) BIOFIRE FILMARRAY Gastrointestinal (GI) Panel REF RFIT-ASY-0104 (6 kit test) The BIOFIRE FILMARRAY Gastrointestinal (GI) Panel is a qualitative multiplexed nucleic acid-based in vitro diagnostic test intended for use with BIOFIRE¿ FILMARRAY¿ Systems. The BIOFIRE GI Panel is capable of the simultaneous detection and identification of nucleic acids from multiple bacteria, viruses, and parasites directly from stool samples in Cary Blair transport media obtained from individuals with signs and/or symptoms of gastrointestinal infection.

    Reason

    Due to increase of false positive Vibrio/Vibrio Cholerae results when using a certain transport medium.

    Code Info

    Part Number: RFIT-ASY-0116 (30 test kit) UDI-DI code: 00815381020109 0081538102011: All unexpired products are potentially impacted if used in conjunction with the Remel Cary Blair transport medium Part Number: RFIT-ASY-0104 (6 test kit) UDI-DI code: 0081538102011 All unexpired products are potentially impacted if used in conjunction with the Remel Cary Blair transport medium Remel Cary-Blair Transport Medium lot numbers: 743930 769240 712258 782425 732357 742049

    Distribution

    U.S.: Nationwide - AK, AL, AR, AZ, CA, CO, CT, DC, DE, 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, Puerto Rico, RI, SC, SD, TN, TX, UT, VA, Virgin Island, VT, WA, WI, WV, and WY. O.U.S.: Worldwide - AR, AU, AT, BE, BR, CA, CL, HK, CN, CO, CZ, DE, FI, FR, GR, HU, IN, IT, JP, MX, NL, NO, PH, PL, PT, SG, ZA, KR, ES, SE, CH, TW, TH, TR, GB, AL, DZ, AO, AM, BH, BY, BO, BA, BW, BG, CR, HR, CY, CD, DO, AN, EC, SV, EE, FJ, GE, GU, GT, GN, HT, HN, IS, ID, IQ, IE, IL, CI, CI, JO, KE, KW, LV, LB, LT, MO, MY, ML, MR, MD, MN, MA, MM, NP, NZ, NZ, NI, OM, PK, PA, PG, PY, PE, QA, RO, SA, RS, SI, TN, TR, UY, AE, VE, VN, and ZW.

    Quantity

    67,613 kits (or 2,028,309 pouches). Each pouch is used for each individual test.