{
  "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": "2026-08-13",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "140907",
      "product_res_number": "Z-0238-2016",
      "event_date_initiated": "2015-10-02",
      "event_date_posted": "2015-11-06",
      "recall_status": "Terminated",
      "event_date_terminated": "2016-01-29",
      "res_event_number": "72395",
      "product_code": "OTT",
      "product_description": "Focus Diagnostics Anaplasma Phagocytophilum IFA IgM Test Kit, Model No. IF1450M  in vitro diagnostic.",
      "code_info": "26341, 27011",
      "firm_fei_number": "2023365",
      "recalling_firm": "Focus Diagnostics Inc",
      "address_1": "11331 Valley View St",
      "city": "Cypress",
      "state": "CA",
      "postal_code": "90630-5366",
      "additional_info_contact": "714-220-1900",
      "reason_for_recall": "Focus Diagnostics is recalling the Anaplasma phagocytophilum IFA IgM kit because of the potential increase in invalid results.",
      "root_cause_description": "Device Design",
      "action": "A recall letter dated 10/2/15 was sent to distributors who distributed the Anaplasma phagocytophilum IFA IgM (IF1450M) kit lots 26431 and 27011.  The letter informs the customers that Focus Diagnostics received customer complaints of IF1450M with low reactivity, which may result in higher invalid rate. The letter also provides the customers with Focus Diagnostics' recommendations and actions to be taken by the distributors.  Customers with questions or require additional information are instructed to contact Focus Diagnostics' Technical Services department at (562) 240-6550 from 7am to 5pm (PST) or send an email to DxTS@focusdx.com.",
      "product_quantity": "38 kits",
      "distribution_pattern": "Non US (worldwide): Czech Republic, Denmark, Germany, Italy, Spain and Colombia",
      "openfda": {
        "device_name": "Research Use Only/Microbiology",
        "medical_specialty_description": "Unknown",
        "regulation_number": "",
        "device_class": "N",
        "registration_number": [
          "9610240",
          "3003742580",
          "8022032",
          "3014214006",
          "2023365",
          "3022474803"
        ],
        "fei_number": [
          "3001717360",
          "3003742580",
          "3002808212",
          "3014214006",
          "2023365",
          "3022474803"
        ]
      }
    }
  ]
}