{
  "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": "2026-08-22",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "115438",
      "product_res_number": "Z-0819-2013",
      "event_date_initiated": "2012-12-03",
      "event_date_posted": "2013-02-14",
      "recall_status": "Terminated",
      "event_date_terminated": "2014-01-31",
      "res_event_number": "64017",
      "product_code": "GNX",
      "k_numbers": [
        "K112177"
      ],
      "product_description": "Quidel, Sofia Influenza A + B FIA, Kit #20218 (25-Test Kit), in vitro diagnostic.",
      "code_info": "Lot # Range: 208228-214385, 707916-708108 (29 lots).",
      "firm_fei_number": "2024674",
      "recalling_firm": "Quidel Corporation",
      "address_1": "10165 Mckellar Ct",
      "city": "San Diego",
      "state": "CA",
      "postal_code": "92121-4201",
      "additional_info_contact": "858-552-1100 Ext. 7922",
      "reason_for_recall": "Quidel Corporation has initiated a voluntary recall of specific lots of the Sofia Influenza A+B FIA kits because of false positive results which may lead to misdiagnosis.",
      "root_cause_description": "Nonconforming Material/Component",
      "action": "Quidel Corporation sent a Medical Device Recall dated December 3, 2012, to all affected customers.  The letter identified the product, the problem, and the action to be taken by the customer.   Customers were instructed to check their inventory for the affected product and remove the affected product  from their inventory.  Customers should contact Quide Corporation for instructions on how to obtain replacement product.  Customers were instructed to fax the enclosed inventory Form to Quidel at 858-552-7905.\r\nFor technical support customers should call 800-874-1517 or 858-552-1100.\r\nFor questions regarding this recall call 858-552-1100, ext 7922.",
      "product_quantity": "13,090 kits (327,250 tests)",
      "distribution_pattern": "Worldwide Distribution - USA (nationwide) and internationally to Korea, Norway, Germany, Chile, Hong Kong, Switzerland, Netherlands, Thailand, Japan, China, and the UK",
      "openfda": {
        "k_number": [
          "K971494",
          "K901493",
          "K893579",
          "K132352",
          "K924006",
          "K871231",
          "K131599",
          "K131804",
          "K802931",
          "K871233",
          "K843659",
          "K123182",
          "K884191",
          "K133411",
          "K131606",
          "K843660",
          "K131619",
          "K872958"
        ],
        "registration_number": [
          "3033507883",
          "3003750284",
          "3026664926",
          "2030538",
          "9615056",
          "3023228837",
          "8010096",
          "3043226252",
          "3012494290",
          "3002792284",
          "3014150341",
          "3013530901"
        ],
        "fei_number": [
          "3033507883",
          "3003750284",
          "3026664926",
          "3006224287",
          "3023228837",
          "1000186023",
          "1000520007",
          "3043226252",
          "3012494290",
          "3002792284",
          "3014150341",
          "3013530901"
        ],
        "device_name": "Antigens, Cf (Including Cf Control), Influenza Virus A, B, C",
        "medical_specialty_description": "Microbiology",
        "regulation_number": "866.3330",
        "device_class": "1"
      }
    }
  ]
}