{
  "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": "2026-08-15",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
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  },
  "results": [
    {
      "cfres_id": "140961",
      "product_res_number": "Z-0239-2016",
      "event_date_initiated": "2015-10-13",
      "event_date_posted": "2015-11-06",
      "recall_status": "Terminated",
      "event_date_terminated": "2016-04-13",
      "res_event_number": "72408",
      "product_code": "DHX",
      "k_numbers": [
        "K031270"
      ],
      "product_description": "Access CEA Assay, Part No. 33200.  For the quantitative determination of Carcinoembryonic Antigen (CEA) levels in human serum.",
      "code_info": "595027 595029",
      "firm_fei_number": "2050012",
      "recalling_firm": "Beckman Coulter Inc.",
      "address_1": "250 S Kraemer Blvd",
      "city": "Brea",
      "state": "CA",
      "postal_code": "92821-6232",
      "reason_for_recall": "Beckman Coulter is recalling the Access CEA reagent packs because they were filled incorrectly.",
      "root_cause_description": "Under Investigation by firm",
      "action": "An Urgent Medical Device Recall letter dated 10/13/15 was sent to all customers who purchased the Access CEA Reagent Kit to inform them that Beckman Coulter has determined that the Access CEA reagent packs (P/N 33200) were filled incorrectly.  The packs contain insufficient quantity of reagents in one of the pack wells.  The letter informs the customers of the impact and the actions to be taken.  Customers are instructed to complete and return the enclosed response form within 10 days.  Customers with questions are instructed to contact Beckman Coulter's Customer Technical Support at http://www.beckmancoulter.com, (800) 854-3633 in the US and Canada.  Customers outside of the US and Canada are instructed to contact their local Beckman Coulter representative.",
      "product_quantity": "11,406 units total (1,660 units)",
      "distribution_pattern": "Worldwide Distribution-US (nationwide) and the countries of  Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, China, Croatia, Czech Republic, Egypt, France, Germany, Ghana, Gibraltar, Greece, Guam, Hong Kong, Hungary, India, Ireland, Israel, Italy, Japan, Republic of Korea, Lebanon, Mexico, Morocco, Myanmar, Netherlands, Pakistan, Poland, Portugal, Russian Federation, Saudi Arabia, Serbia, Slovakia, South Africa, Spain, Switzerland, Taiwan, Thailand, Turkey, United Kingdom, and Vietnam.",
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          "P920021",
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        "registration_number": [
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        ],
        "device_name": "System, Test, Carcinoembryonic Antigen",
        "medical_specialty_description": "Immunology",
        "regulation_number": "866.6010",
        "device_class": "2"
      }
    }
  ]
}