{
  "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": "112672",
      "product_res_number": "Z-0016-2013",
      "event_date_initiated": "2012-01-20",
      "event_date_posted": "2012-10-05",
      "recall_status": "Terminated",
      "event_date_terminated": "2012-10-05",
      "res_event_number": "63140",
      "product_code": "CIB",
      "k_numbers": [
        "K981607"
      ],
      "product_description": "Active Renin IRMA Kit, Part Number DSL25100\n\nProduct Usage:\nThe Renin IRMA; DSL25100 immunoradiometric assay kit provides materials for the quantitative measurement of Renin in plasma. This assay is intended for in vitro diagnostic use.",
      "code_info": "Lot # 110919D, 111017C, 111017D, 111114C, 111212C.",
      "firm_fei_number": "2050012",
      "recalling_firm": "Beckman Coulter Inc.",
      "address_1": "250 S Kraemer Blvd MS/E1.NE.02",
      "city": "Brea",
      "state": "CA",
      "postal_code": "92821-6232",
      "additional_info_contact": "Clair K. O'Donovan, Ph.D.\n714-961-4483",
      "reason_for_recall": "The recall was initiated because Beckman Coulter has confirmed that the Active Renin IRMA Test Kit may exhibit a decrease in stability of the coated tubes.  As a result, quality control and patient sample results may be falsely elevated by up to 72%.",
      "root_cause_description": "Nonconforming Material/Component",
      "action": "Beckman Coulter sent an Urgent Production Correction letter dated January 10, 2012 to all their customers who purchased the Manual Immunoassay Active Renin IRMA Test Kit.  The letter provides the customers with an explanation of the problem and actions to be taken.  Customers were instructed to discontinue use and discard all remaining affected inventory.  Customers were asked to complete and return the enclosed Response Form with in 10 days.  Customers with questions contact Customer Service Support at http://www.beckmancoulter.com/customersupport/support or call (800) 854-3633.",
      "product_quantity": "216 units total (6 units in the US)",
      "distribution_pattern": "Worldwide Distribution - US Natiowide including the state of: OH, CT, CA and the state of Argentina, Austria, Belgium, Brazil, Canada, China, Columbia, Czech Republic, France, Germany, Greece, Hungary, Italy, Kuwait, Netherlands, Poland, Portugal, Slovakia, Spain, Switzerland, Turkey, and United Kingdom.",
      "openfda": {
        "k_number": [
          "K123763",
          "K061758",
          "K954299",
          "K011128",
          "K800774",
          "K833777",
          "K850054",
          "K062120",
          "K981607",
          "K761267",
          "K820616",
          "K842966",
          "K925998",
          "K940004",
          "K121944",
          "K831694"
        ],
        "registration_number": [
          "9610240",
          "8021924",
          "3007118747"
        ],
        "fei_number": [
          "3002485711",
          "3002808212",
          "3007118747"
        ],
        "device_name": "Radioimmunoassay, Angiotensin I And Renin",
        "medical_specialty_description": "Clinical Chemistry",
        "regulation_number": "862.1085",
        "device_class": "2"
      }
    }
  ]
}