BEUDAMED
    FDA Recall Open, Classified

    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 · Initiated January 26, 2024

    Recall

    Recall Number
    Z-1139-2024
    Event Number
    93636
    Firm
    BioFire Diagnostics, LLC
    FEI Number
    3002773840
    Product Code
    PEN
    Status
    Open, Classified
    Root Cause
    Under Investigation by firm
    Initiated
    January 26, 2024
    Posted
    February 15, 2024
    Address
    515 S Colorow Dr, Salt Lake City, UT, 84108-1248

    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

    Action

    On 01/26/2024, the firm sent an "URGENT: MEDICAL DEVICE RECALL" Letter via overnight FedEx to customers to inform them of the increased risk of false positive Candida tropicalis results when the BIOFIRE BCID2 Panel is used with BD BACTEC blood culture vials including, but not limited to, the bottle types: 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 Customers are requested to take the following actions: - If the BIOFIRE BCID2 Panel is used to test BD BACTEC blood culture vials, positive results for Candida tropicalis should be confirmed by another method prior to reporting the test results. - Distribute this information to all appropriate personnel in their laboratory, retain a copy in their files, and forward this information to all parties that may use this product, including others to whom they may have transferred the product. - Complete the Acknowledgement Form in Attachment A and return it to bioMerieux so that bioMerieux may acknowledge their receipt of this notification. It is important that they return the acknowledgement form to bioMerieux even if they determine that this urgent field safety notice does not impact their facility. For questions/assistance contact BIOFIRE Technical Support Team at [email protected] or via telephone at 1-800-735-6544 and select option 5.

    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