{
  "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": "49841",
      "product_res_number": "Z-0417-2007",
      "event_date_initiated": "2006-10-26",
      "event_date_posted": "2007-02-07",
      "recall_status": "Terminated",
      "event_date_terminated": "2012-04-30",
      "res_event_number": "37065",
      "product_code": "DDC",
      "k_numbers": [
        "K012208"
      ],
      "product_description": "Access Immunoassay Systems Thyroglobulin Antibody Reagent Kit, Part Number 33890",
      "code_info": "518729 (expires 10/31/06); 520617 (expires 12/31/06); 612764 (expires 12/31/06); 613481 (expires 3/31/07); 614541 (expires 5/31/07); 616787 (expires 8/31/07)",
      "firm_fei_number": "2050012",
      "recalling_firm": "Beckman Coulter Inc",
      "address_1": "200 S Kraemer Blvd",
      "city": "Brea",
      "state": "CA",
      "postal_code": "92822-6208",
      "additional_info_contact": "Nora Zerounian\n714-961-3634",
      "reason_for_recall": "Low end imprecision affecting both S0 calibrators and patient samples which can lead to inaccurate low level patient results when using the Access Thyroglobulin Antibody assay.",
      "root_cause_description": "Other",
      "action": "A Product Corrective Action (PCA) letter was mailed on Oct 27, 2006 to all Thyroglobulin Antibody customers. They are informed that there has been an increase in customer feedback regarding low end imprecision affecting both S0 calibrators and patient samples, which can lead to inaccurate low level patient results when using the Access Thyroglobulin Antibody assay. The letter informs the customer that the firm recommends that they use an alternate method for testing TgAb. (Letter was sent by US mail).  Customers are asked to complete and return the enclosed response form within 10 days.",
      "product_quantity": "474 units",
      "distribution_pattern": "Nationwide and Canada",
      "openfda": {
        "k_number": [
          "K991179",
          "K991610",
          "K012208",
          "K865020",
          "K943625",
          "K930486",
          "K953066",
          "K936010",
          "K780874",
          "K971835",
          "K000363",
          "K780873",
          "K023592"
        ],
        "registration_number": [
          "2245285",
          "2242436",
          "3003750284",
          "9612316",
          "2029372",
          "2020726",
          "3012348571",
          "3022178699",
          "3002800697",
          "2026994",
          "8031673"
        ],
        "fei_number": [
          "2245285",
          "3002808328",
          "2242436",
          "3003750284",
          "1000306617",
          "3012348571",
          "3022178699",
          "3002800697",
          "2967",
          "2026994",
          "2020726"
        ],
        "device_name": "Thyroglobulin, Antigen, Antiserum, Control",
        "medical_specialty_description": "Immunology",
        "regulation_number": "866.5870",
        "device_class": "2"
      }
    }
  ]
}