{
  "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": "2026-09-12",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "216846",
      "product_res_number": "Z-0602-2026",
      "event_date_initiated": "2025-10-22",
      "event_date_posted": "2025-11-26",
      "recall_status": "Open, Classified",
      "res_event_number": "97870",
      "product_code": "QOF",
      "product_description": "BioFire Respiratory Panel 2.1, IVD, REF: 423742 (30 test kit)",
      "code_info": "UDI: 00815381020529 /Lot # 2649724\nExpanded Lot#: 1471725",
      "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\n1800-736-6354 Ext. 360",
      "reason_for_recall": "Due to  unintended movement of pouch chemistry,  nucleic acid test may result in elevated risk of false negative results and risk of control failures.",
      "root_cause_description": "Under Investigation by firm",
      "action": "On  May 28, 2026, Biomerieux issued a \"Urgent: Medical Device Recall\" Expansion Notification to affected consignees via E-Mail. Initial notification was sent out on October 22, 2025. Biomerieux asked consignees to take the following actions: \n\n1. Examine your inventory for the lot identified in this field safety notice.\n\n2. Discontinue use and discard any remaining product from this lot in your possession.\n\n3. Please confirm the quantity of kits that have been destroyed, previously used, or returned on the attached Acknowledgement of Receipt Form.\n\n4. If you have further distributed this product, please identify any recipients and notify them at once.\n\n5. Please complete the accompanying Acknowledgement of Receipt Form and return to bioMrieux so that bioMrieux may acknowledge your receipt of this notification.\n\n6. Complete and submit the report online. Regular Mail or Fax: Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form or submit by fax to 1-800-FDA-0178.",
      "product_quantity": "97 Kits (2,910 pouches)",
      "distribution_pattern": "US:AZ, FL,GA,ID NC, NH, NJ, NY, OR, PA, SC\nOUS: None",
      "openfda": {
        "k_number": [
          "K241652",
          "K220963",
          "K243406",
          "K241240",
          "K241194",
          "K230956",
          "K241573",
          "K230719",
          "K231481",
          "K243400",
          "K233410",
          "K231758",
          "K251742",
          "K252932",
          "K222736",
          "K242526",
          "K243544",
          "K223591",
          "K241806",
          "K242465",
          "K250080",
          "K251978",
          "K242353",
          "K252387",
          "K243455",
          "K250996",
          "K250995",
          "K252269",
          "K242071",
          "K233100",
          "K232954",
          "K213954",
          "DEN200031"
        ],
        "registration_number": [
          "3009613136",
          "1528450",
          "3008632402",
          "3004013603",
          "3005248192",
          "3035381641",
          "3016838963",
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        ],
        "fei_number": [
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          "3044563551",
          "3002773840",
          "3010770794",
          "2023365",
          "3014515702",
          "3011104381"
        ],
        "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"
      }
    }
  ]
}