{
  "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": "219560",
      "product_res_number": "Z-2081-2026",
      "event_date_initiated": "2026-04-01",
      "event_date_posted": "2026-05-06",
      "recall_status": "Open, Classified",
      "res_event_number": "98719",
      "product_code": "QOF",
      "k_numbers": [
        "K232954"
      ],
      "product_description": "Biofire Spotfire Respiratory/Sore Throat Panel\nREF: 423485",
      "code_info": "Lot Number: 2215125/UDI: 00815381020390",
      "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": "BioFire Diagnostics Customer Support \n801-736-6354 Ext. 360",
      "reason_for_recall": "Respiratory/sore throat panel  test may result in false negative results and control failures.",
      "root_cause_description": "Under Investigation by firm",
      "action": "On April 1, 2026, Biomerieux, issued a \"Urgent Medical Device Recall\"  via E-Mail. Biomerieux ask consignees to take the following actions:\n\nIn this context, we request that you take the following actions:\n\n\" Examine your inventory for the lot identified in this recall notice.\n\n\"Discontinue use and discard any remaining product from this lot in your possession.\n\n\"Please confirm the quantity of kits that have been destroyed, previously used, or returned on the attached Acknowledgement of Receipt Form.\n\n\"If you have further distributed this product, please identify any recipients and notify them at once.\n\n\" Please complete the accompanying Acknowledgement of Receipt Form and return to bioMrieux.",
      "product_quantity": "2400 pouches",
      "distribution_pattern": "US Nationwide distribution in the states of MS, TX MN, VA.",
      "openfda": {
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        "device_name": "Multi-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents",
        "medical_specialty_description": "Microbiology",
        "regulation_number": "866.3981",
        "device_class": "2",
        "registration_number": [
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      }
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}