BEUDAMED
    FDA Enforcement Class II Ongoing

    BIOFIRE Blood Culture Identification 2 (BCID2) Panel when used with: BD BACTEC Lytic Anaerobic medium BD BACTEC Peds Plus medium BD BACTEC Plus Aerobic medium BD BACTEC Plus Anaerobic medium BD BACTEC Standard Aerobic medium BD BACTEC Standard Anaerobic medium The BIOFIRE Blood Culture Identification 2 (BCID2) Panel is a multiplex nucleic acid assay for identification of microorganisms and resistance markers from positive blood cultures.

    Recall: Z-1139-2024 · Reported February 21, 2024

    Enforcement

    Recall Number
    Z-1139-2024
    Event ID
    93636
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    BioFire Diagnostics, LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    February 21, 2024
    Initiation Date
    January 26, 2024
    Classification Date
    February 15, 2024
    Address
    515 S Colorow Dr, N/A, Salt Lake City, UT, 84108-1248, United States

    Description

    BIOFIRE Blood Culture Identification 2 (BCID2) Panel when used with: BD BACTEC Lytic Anaerobic medium BD BACTEC Peds Plus medium BD BACTEC Plus Aerobic medium BD BACTEC Plus Anaerobic medium BD BACTEC Standard Aerobic medium BD BACTEC Standard Anaerobic medium The BIOFIRE Blood Culture Identification 2 (BCID2) Panel is a multiplex nucleic acid assay for identification of microorganisms and resistance markers from positive blood cultures.

    Reason

    Due to a trend in false positive Candida tropicalis results on blood culture panel when using certain BD BACTEC vial mediums

    Code Info

    For BioFire Blood Culture Identification 2 (BDID2) Panel Part Number: RFIT-ASY-0147 UDI-DI code: 00815381020338 Lot Numbers: All non-expired BCID2 Panel lots, if used with the BD BACTEC vials including but not limited to, the bottle types listed in Table 1. NOTE: The affected blood culture vial types most likely contain non-viable Candida tropicalis nucleic acid/DNA fragments that can be detected by the BCID2 Panel. Therefore, all lots of the BioFire BCID2 Panel would be affected if they are used with the affected blood culture vials. Neither the BioFire BCID2 test kits nor the BD BACTEC vials have a defect - both products are performing as intended.

    Distribution

    Worldwide - U.S. Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, Guam, 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, VT, WA, WI, WV, and WY. The countries of Andorra, United Arab Emirates, Armenia, Argentina, Austria, Australia, Bosnia, Belgium, Bulgaria, Bahrain, Brunei, Bolivia, Brazil, Canada, Switzerland, Cote D'Ivoire, Chile, China, Colombia, Costa Rica, Cyprus, Cech Republic, Germany, Denmark, Dominican Republic, Algeria, Ecuador, Estonia, Egypt, Spain, Finland, France, Gabon, United Kingdom, Georgia, Guadeloupe, Greece, Guatemala, Hong Kong, Honduras, Croatia, Hungary, Iceland, Indonesia, Ireland, Israel, India, Italy, Jordan, Japan, Korea, Kuwait, Lebanon, Lithuania, Latvia, Morocco, Macedonia, Mali, Mongolia, Macau, Mexico, Malaysia, New Caledonia, Nigeria, Nicaragua, Netherlands, Norway, New Zealand, Oman, Panama, Peru, French Polynesia, Philippines, Pakistan, Poland, St. Pierre/Miquelon, Portugal, Paraguay, Qatar, Reunion, Romania, Serbia, Saudi Arabia, Sweden, Singapore, Slovenia, Slovakia, El Salvador, Thailand, Tunisia, Turkey, Taiwan, Uganda, Uruguay, Vatican City, Venezuela, Vietnam, South Africa, and Zimbabwe.

    Quantity

    32,910 panels/pouches