{
  "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": "2026-09-20",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 3
    }
  },
  "results": [
    {
      "cfres_id": "198407",
      "product_res_number": "Z-1251-2023",
      "event_date_initiated": "2023-02-01",
      "event_date_posted": "2023-03-15",
      "recall_status": "Open, Classified",
      "res_event_number": "91647",
      "product_code": "PEN",
      "k_numbers": [
        "K193519"
      ],
      "product_description": "In Vitro Diagnostic (IVD) Panel\n\nBioFire BCID2 Panel - REF RFIT-ASY-0147",
      "code_info": "Part Number: RFIT-ASY-0147\nUDI: 0815381020338\nPouch Lot Number: 1766022",
      "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 Department\n800-736-6354 Ext. 5",
      "reason_for_recall": "Due to temperature excursions with products (products being stored outside of the required temperature specifications) that may cause a reduction in performance.  The temperature excursion was as a result of shipping delays.",
      "root_cause_description": "Environmental control",
      "action": "On 02/01/2023, the firm sent an \"URGENT: MEDICAL DEVICE CORRECTION\" Letter via email to customers informing them of a \"Temperature Out of Range\" issue with multiple products, as a result from Hurricane Ian (10/2022)\n\nCustomers are Instructed to:\nImmediately examine their inventory for product identified in this recall.\n1. Discontinue use and discard any remaining product in their possession that is subject to this recall. bioMerieux will replace the product at no charge in accordance with BIOFIRE s standard limited warranty.\n2. Complete the accompanying Acknowledgment of Receipt Form and confirm the number of pouches scrapped (if any). Return the Acknowledgment of Receipt to bioMerieux so that bioMerieux may acknowledge their receipt of this notification.\n3. If customers have further distributed this product, please identify any recipients, and notify them at once of this product recall.\n\nFor questions or concerns, contact customer support department at biofiresupport@biomerieux.com or via telephone by dialing +1.800.736.6354 and selecting option 5 for Product Technical Support",
      "product_quantity": "2 kits",
      "distribution_pattern": "U.S. Nationwide distribution in the states of FL and GA.",
      "openfda": {
        "k_number": [
          "K160457",
          "K213236",
          "K193519",
          "K130914",
          "K190341",
          "K243013",
          "K243759",
          "K143171",
          "K181493",
          "K182619",
          "K132843"
        ],
        "device_name": "Gram-Negative Bacteria And Associated Resistance Markers",
        "medical_specialty_description": "Microbiology",
        "regulation_number": "866.3365",
        "device_class": "2",
        "registration_number": [
          "3006028115",
          "3010749841",
          "3014553740",
          "3008632402",
          "3004013603",
          "3002773840"
        ],
        "fei_number": [
          "3006028115",
          "3010749841",
          "3014553740",
          "3008632402",
          "3004013603",
          "3002773840"
        ]
      }
    }
  ]
}