{
  "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": "2026-04-08",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Brea",
      "state": "CA",
      "country": "United States",
      "classification": "Class I",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "81039",
      "recalling_firm": "Beckman Coulter Inc.",
      "address_1": "250 S Kraemer Blvd",
      "address_2": "N/A",
      "postal_code": "92821-6232",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "E-Mail",
      "distribution_pattern": "Worldwide distribution.  US Nationwide including Puerto Rico.    OUS:  FC 500:  Japan, South Korea, China, Italy, Spain, United Kingdom, Germany, Bangladesh, Czech Republic, France, Pakistan, India, South Africa, Austria, Saudi Arabia, Algeria, Turkey, Belgium, Netherlands, Bulgaria, Sweden, Australia, Hungary, Sri Lanka, Uruguay, Canada, New Zealand, Switzerland, Gabon, Portugal, Mexico, Singapore, Monaco, Hong Kong, Guadeloupe, Zambia, United Arab Emirates, Ireland, Reunion, Poland, Egypt, Slovakia, Croatia, Brazil, Chile, Bahrain, Slovenia, Bosnia and Herzegovina, Greece, Myanmar, Morocco, Serbia, Philippines, Lebanon, Romania, Moldova, Qatar, Barbados, Iraq, Oman, Namibia, Indonesia, Thailand, The Bahamas, Macau, El Salvador, Panama, Denmark, Venezuela, Azerbaijan, Israel, Colombia, Peru, Malaysia, Vietnam, Tunisia, Kuwait, Kenya, Libya, Latvia, Russia, Belarus, Ukraine, Kazakhstan, Taiwan    EPICS XL:  Albania, Algeria, Angola, Australia, Austria, Azerbaijan, Bahrain, Bangladesh, Belarus, Botswana, Bulgaria, Burundi, Cameroon, Canada, China, Congo, Croatia, Cyprus, Czech Republic, Denmark, Dominican, Republic, Egypt, Ethiopia, France, Germany, Greece, Guinea, Guinea-Bissau, Hong Kong, India, Indonesia, Ireland, Israel, Italy, Japan, Kazakhstan, Kenya, Kuwait, Lebanon, Lesotho, Libya, Macau, Malawi, Mexico, Morocco, Mozambique, Namibia, Netherlands, New Zealand, Nigeria, Oman, Pakistan, Poland, Portugal, Qatar, Romania, Russia, Saudi Arabia, Singapore, Slovakia, South Africa, South Korea, Spain, Sri Lanka, Sudan, Swaziland, Sweden, Switzerland, Syria, Taiwan, Tanzania, The Bahamas, Tunisia, Turkey, Turkmenistan, Uganda, Ukraine, United Arab Emirates, United Kingdom, Zambia, Zimbabwe",
      "recall_number": "Z-0471-2019",
      "product_description": "1) Cytomics FC 500 With CXP Software  BECKMAN COULTER    2) Cytomics FC 500 MPL With MXP Software BECKMAN COULTER    flow cytometer for in vitro diagnostics",
      "product_quantity": "3115",
      "reason_for_recall": "A manufacturing defect on the amplifier board of the Flow Cytometers my cause signal loss and/or signal drifting resulting in absence of data or a population shift in the data plots.  This can impact patient results for any application.",
      "recall_initiation_date": "20180112",
      "center_classification_date": "20181120",
      "termination_date": "20240430",
      "report_date": "20181128",
      "code_info": "FC 500                                                                                            Catalog Num  FC 500\" Flow Cytometer MCL with UPS                                        626553  FC 500\" Flow Cytometer MPL                                                        626554  FC 500\" MCL Flow Cytometer 5 Color (100V)                               6605627  FC 500\" MCL Flow Cytometer 5 Color (120V)                               6605628  FC 500\" MCL Flow Cytometer 5 Color (220V)                               6605629  FC 500\" MCL Flow Cytometer 5 Color (240V)                               6605630   FC 500 Flow Cytometer, Remfg Assy, 5 Clr (220V)                       A89264   FC 500\" Flow Cytometer 100-240V, 50-60HZ, Remfg Assy          A89151  FC 500 Recond MCL UPS Flow Cytometer 100-240V, 50-60HZ  A88262  FC 500 Flow Cytometer 100-240V                                                A88263    All products manufactured affected for the time period:  FC-500 From 01/22/2002 to 01/31/2018  EPICS XL/XL-MCL From 11/01/1992 to 03/15/2013",
      "more_code_info": ""
    }
  ]
}