{
  "meta": {
    "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.",
    "terms": "https://open.fda.gov/terms/",
    "license": "https://open.fda.gov/license/",
    "last_updated": "2026-07-08",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Ongoing",
      "city": "Salt Lake City",
      "state": "UT",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "93636",
      "recalling_firm": "BioFire Diagnostics, LLC",
      "address_1": "515 S Colorow Dr",
      "address_2": "N/A",
      "postal_code": "84108-1248",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "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.",
      "recall_number": "Z-1139-2024",
      "product_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.",
      "product_quantity": "32,910 panels/pouches",
      "reason_for_recall": "Due to a trend in false positive Candida tropicalis results on blood culture panel when using certain BD BACTEC vial mediums",
      "recall_initiation_date": "20240126",
      "center_classification_date": "20240215",
      "report_date": "20240221",
      "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."
    }
  ]
}