{
  "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": "2026-04-22",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Brea",
      "state": "CA",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "63158",
      "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": "Letter",
      "distribution_pattern": "Worldwide Distribution-USA (nationwide) and the counties of  Australia, Belgium, Canada, Colombia, Croatia, Czech Republic, France, Germany, Greece, Hong Kong, Hungary, India, Israel, Italy, Japan, Korea, Republic of Kuwait, Macao, Malaysia, Mexico, Netherlands, Norway, Oman, Panama, Philippines, Puerto Rico, Qatar, Romania, Russian, Federation, Saudi Arabia, Singapore, Slovakia, Slovenia, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, and United Kingdom.",
      "recall_number": "Z-0021-2013",
      "product_description": "Unicel DxH 800 Coulter Cellular Analysis System, Part Number 629029.    The UniCel DxH 800 Analyzer is a quantitative, automated hematology analyzer for in vitro diagnostic use in screening patient populations found in clinical laboratories. The UniCel DxH 800 Analyzer provides a: \" Complete Blood Count (CBC), Leukocyte 5 Part Differential (Diff), Reticulocyte (Retic) and Nucleated Red Blood Cell (NRBC) on whole blood. \" Total Nucleated Count (TNC) and Red Cell Count (RBC) on Body Fluids (cerebrospinal, serous and synovial) (BF).",
      "product_quantity": "1281 units total (693 units in the US)",
      "reason_for_recall": "Beckman Coulter is recalling the UniCel DxH 800 Coulter Cellular Analysis System because the NRBC, Differential or Reticulocyte mix chamber drain ports may become plugged by rubber pieces from specimen tube caps, and result in biohazard or chemical exposure and/or the potential for generating incorrect results.",
      "recall_initiation_date": "20120403",
      "center_classification_date": "20121009",
      "termination_date": "20130620",
      "report_date": "20121017",
      "code_info": "all serial numbers"
    }
  ]
}