{
  "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": "2026-09-05",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "219761",
      "product_res_number": "Z-2067-2026",
      "event_date_initiated": "2026-04-22",
      "event_date_posted": "2026-05-06",
      "recall_status": "Open, Classified",
      "res_event_number": "98776",
      "product_code": "QSN",
      "product_description": "BioFire Joint Infection (JI) Panel\nREF: RFIT-ASY-0138, 30 test Kit.",
      "code_info": "Lot #s:0883425,0878825/DI: 00815381020192",
      "firm_fei_number": "3002773840",
      "recalling_firm": "BioFire Diagnostics, LLC",
      "address_1": "515 S Colorow Dr",
      "city": "Salt Lake City",
      "state": "UT",
      "postal_code": "84108-1248",
      "additional_info_contact": "Customer Support Dept. \n1800-736-6354 Ext. 360",
      "reason_for_recall": "Contamination to in-vitro diagnostic test   may result in false positives.",
      "root_cause_description": "Under Investigation by firm",
      "action": "On April 22, 2026, bioMerieux issued a Urgent Medical Device Recall notification to affected consignees via E-Mail. bioMerieux asked consignees to take the following actions: \n\n1\tExamine your inventory for the lots identified in this recall notification.\n2\tDiscontinue use and discard any remaining product from this lot in your possession.\n3\tPlease confirm the quantity of kits that have been destroyed, previously used, or returned on the attached Acknowledgement of Receipt Form.\n4\tIf the product has been transferred to another facility, please notify the facility and appropriate personnel. \n5\tIf you have further distributed this product, please identify any recipients and notify them at once.\n6\tPlease complete the accompanying Acknowledgement of Receipt Form and return to bioMrieux so that bioMrieux may acknowledge your receipt of this notification.",
      "product_quantity": "106 kits (3,180 test)",
      "distribution_pattern": "Worldwide - US Nationwide distribution in the states of TX, NC, UT, MD and the countries of France, Italy, Germany, Spain, Belgium, Switzerland, United Kingdom, Netherlands, Poland, Austria, India, Finland, Czech Republic, Egypt, Lebanon, Morocco, Slovenia, Romania, \tDominican Republic, Serbia.",
      "openfda": {
        "k_number": [
          "DEN200066"
        ],
        "registration_number": [
          "3002773840"
        ],
        "fei_number": [
          "3002773840"
        ],
        "device_name": "Orthopedic Infection Microbial Multiplex Nucleic Acid Detection System",
        "medical_specialty_description": "Microbiology",
        "regulation_number": "866.3988",
        "device_class": "2"
      }
    }
  ]
}