{
  "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,
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  },
  "results": [
    {
      "cfres_id": "112770",
      "product_res_number": "Z-0046-2013",
      "event_date_initiated": "2012-07-24",
      "event_date_posted": "2012-10-10",
      "recall_status": "Terminated",
      "event_date_terminated": "2013-10-17",
      "res_event_number": "63169",
      "product_code": "CGN",
      "k_numbers": [
        "K060774"
      ],
      "product_description": "Access Folate Calibrators, Part Number: A14207.\n\nThe Access Folate assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of folic acid levels in human serum, plasma (heparin) or red blood cells using the Access Immunoassay Systems. The serum folate level is an indicator of recent folate intake. A low RBC folate value can indicate a prolonged folate deficiency. The Access Folate Calibrators are intended to calibrate the Access Folate assay using the Access Immunoassay Systems.",
      "code_info": "Lot# 112788, 115741, 118917",
      "firm_fei_number": "2050012",
      "recalling_firm": "Beckman Coulter Inc.",
      "address_1": "250 S Kraemer Blvd",
      "city": "Brea",
      "state": "CA",
      "postal_code": "92821-6232",
      "additional_info_contact": "Clair K. O'Donovan, Ph.D.\n714-961-4483",
      "reason_for_recall": "Beckman Coulter is recalling the Access Folate Calibrators because it may produce falsely elevated results that could mask a folate deficiency.",
      "root_cause_description": "Nonconforming Material/Component",
      "action": "Beckman Coulter sent an \"URGENT PRODUCT CORRECTION\" letter dated July 24, 2012 to all affected customers.  The letter identified the product, problem, and the actions to be taken by the customers.  Customers were instructed to complete and return the enclosed Response Forms within 10 days.  Customers with questions were instructed to call (800) 854-3633 in the US and Canada.  Outside of the US and Canada, customers were instructed to contact their local Beckman Coulter representative.",
      "product_quantity": "4,635 units total (3,214 units in US)",
      "distribution_pattern": "Worldwide Distribution-USA (nationwide) and the countries of  Argentina, Austria, Australia, Bangladesh, Belgium, Botswana, Brazil, Canada, China, Colombia, Czech Republic, Croatia, Ecuador, Ethiopia, Finland, France, Georgia, Germany, Greece, Guatemala, Honduras, Hong Kong, Hungary, India, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Kuwait, Lebanon, Libyan Arab Jamahiriya, Malaysia, Mexico, Morocco, Namibia, Netherlands, New Zealand, Oman, Pakistan, Panama, Philippines, Poland, Puerto Rico, Qatar, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Switzerland, Sweden, Taiwan, Thailand, Tunisia, Turkey, United Arab Emirates, United Kingdom, Venezuela, Viet Nam, and Zimbabwe.",
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        "device_name": "Acid, Folic, Radioimmunoassay",
        "medical_specialty_description": "Clinical Chemistry",
        "regulation_number": "862.1295",
        "device_class": "2"
      }
    }
  ]
}