{
  "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-0472-2019",
      "product_description": "COULTER EPICS XL Flow Cytometer  COULTER EPICS XL-MCL Flow Cytometer  SYSTEM II Software",
      "product_quantity": "2549",
      "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": "EPICS                                                                                    Catalog Number:  EPICS CL 3 COLOR W/MCL 220V                                       6604985  XL 4CLR FLOW CENTRE 220V AC                                     6605465  PKG; 4 COLOR XL M/M (220V)                                            6605465R  XL-MCL 4 CLR FLOW CENTRE 220V A                               6605437  XL-MCL 4 CLR FLOW CENTRE 240V AC                            6605438  XL-MCL 4 CLR FLOW CENTRE 220V A                               6605437R  EPICS XL 4 COLORS 115V                                                   6604714    XL-MCL 4CLR FLOW CENTRE 100VAC                               6605435    TN, XL Flow Cytometer 100-240V, 50/60Hz                           626551    EPICS XL 3 COLOR 230V                                                     6604726  EPICS XL 4 CLR/ MCL 115V                                                 6604988  EPICS XL 4 CLR/ MCL 220V                                                 6604989      XL 4CLR FLOW CENTRE 240VAC                                        6605466    R-EPICS XL 3 COLOR 115V                                                  6604713  XL 4 CLR W/FLOW 1 YR WARR                                            6605464  PKG;4 COLOR XL M/M (100V)                                               6605463  EPICS XL 4 COLOR 220V                                                      6604723  TN, XL/MCL Flow Cytometer 100-240V, 50/60Hz                   626552  EPICS XL 3 COLOR 240V                                                      6604725  EPICS XL 4 CLR/MCL 240V                                                   6604990    4 CLR,MCL,MM(120V)REFURB                                             6605436R     XL-MCL 4 CLR FLOWCENTRE 240VAC                               6605438R         4 COLOR XL M/M (120V)REFURB                                        6605464R  XL 4CLR FLOW CENTRE 240VAC                                       6605466R         4 CLR, MCL, MM PKG (240V)                                               6605438U     XL-MCL 4 CLR W/FLOW (RECOND)                                    6605436U    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": ""
    }
  ]
}