{
  "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": "87282",
      "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": "E-Mail",
      "distribution_pattern": "Worldwide distribution - US Nationwide distribution and the countries of Afghanistan, Angola, Anguilla , Argentina, Australia, Austria, Bahrain, Belarus, Belgium, Bolivia, Brazil, Brunei. Daruss., Bulgaria, Canada, Chile, China, Colombia, Costa Rica, Cote d'Ivoire, Croatia, Czech Republic, Dominican Rep, Dutch Antilles, Ecuador, Egypt, El Salvador, Estonia, France, Georgia, Germany, Greece, Guam, Guatemala, Honduras, Hong Kong, Hungary, India, Indonesia, Israel, Italy, Japan, Jordan, Kenya, Kuwait, Latvia, Lebanon, Macedonia, Malaysia, Mexico, Morocco, Myanmar, Netherlands, Nicaragua, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Romania, Saudi Arabia, Serbia, Singapore, Slovenia, South Korea, Spain, Sweden, Switzerland, Thailand, Tunisia, Turkey, United Kingdom, Uruguay, Utd/Arab Emir/, Vietnam.",
      "recall_number": "Z-1157-2021",
      "product_description": "Gram-Negative Bacteria And Associated Resistance Markers;  Film Array Blood Culture Identification (BCID); Film Array BCID Panel - Product Usage: intended for use with FilmArray systems.  Part No: RFIT-ASY-0126 / UDI: 00815381020086   Part No: RFIT-ASY-0127 / UDI: 00815381020093  IVD, Rx Only",
      "product_quantity": "21,922 kits",
      "reason_for_recall": "The firm has identified an increased risk of false positive Pseudomonas aeruginosa when BCID/BCID2 Panels are used with specific  BD BACTEC\" blood culture vials.",
      "recall_initiation_date": "20210126",
      "center_classification_date": "20210301",
      "termination_date": "20220502",
      "report_date": "20210310",
      "code_info": "All non-expired BCID and BCID2 Panel lots, if used with the BD BACTEC Culture Media vials Catalog No. 442023 and 442020.",
      "more_code_info": ""
    }
  ]
}