{
  "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": "2026-04-01",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Salt Lake City",
      "state": "UT",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "88934",
      "recalling_firm": "BioFire Diagnostics, LLC",
      "address_1": "515 S Colorow Dr",
      "address_2": "",
      "postal_code": "84108-1248",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Worldwide distribution - U.S. Nationwide distribution in the states of AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV and WY. The Countries of Algeria, Argentina, Australia, Austria, Bahrain, Belarus, Belgium, Bulgaria, Chile, Colombia, Costa Rica, Croatia, Czech Republic, Dominican Rep/, Ecuador, Egypt,  France, Georgia, Germany, Greece, Guam, Guatemala, Hong Kong, Hungary, India, Israel Italy, Kuwait, Latvia, Macedonia, Malaysia, Mexico, Netherlands, Panama, Paraguay,  Peru, Philippines, Poland, Portugal, Qatar, Romania, Russian Fed., Saudi Arabia, Serbia,  Shanghai, Slovenia, South Africa, Spain, Sweden, Switzerland, Thailand, Tunisia, Turkey, United Kingdom, Uruguay, Utd/Arab Emir/.",
      "recall_number": "Z-0312-2022",
      "product_description": "BioFire Blood Culture Identification 2 (BCID2) Panel Part No: RFIT-ASY-0147 UDI: 00815381020338  Blood Culture Catalog No./Description: 442023/BD BACTEC Plus Aerobic medium in plastic vials 442021/BD BACTEC Lytic Anaerobic medium in plastic vials 442192//BD BACTEC Plus Aerobic medium in glass vials 442022/BD BACTEC Plus Anaerobic medium in plastic vials 442020/BD BACTEC Peds Plus mediums in plastic vials  All lots with an expiry date prior to",
      "product_quantity": "Total 14,140 Kits [11,155 kits (U.S.) and 2,985 kits (O.U.S.)]",
      "reason_for_recall": "Due to an increased risk of false positive Acinetobacter calcoaceticus- baumannii complex results.  The cause may be as a due to non-viable contamination in the blood culture vials.",
      "recall_initiation_date": "20211011",
      "center_classification_date": "20211130",
      "termination_date": "20230810",
      "report_date": "20211208",
      "code_info": "Blood Culture Identification 2 (BCID2) Panel Part Number: RFIT-ASY-0147 UDI Code: 00815381020338  Blood Culture Media Catalog No./Description: 442023/BD BACTEC Plus Aerobic medium in plastic vials 442021/BD BACTEC Lytic Anaerobic medium in plastic vials 442192//BD BACTEC Plus Aerobic medium in glass vials 442022/BD BACTEC Plus Anaerobic medium in plastic vials 442020/BD BACTEC Peds Plus mediums in plastic vials  All BCID2 Panel lots BD Blood Culture Media vials with expiration date of April 30, 2022 or earlier.",
      "more_code_info": ""
    }
  ]
}