{
  "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": [
    {
      "country": "United States",
      "city": "Brea",
      "address_1": "250 S Kraemer Blvd",
      "reason_for_recall": "Beckman Coulter, Inc. initiated this recall because there is a software error that has the potential to cause the reporting of erroneous patient results because of misidentification by the AU5800 system.",
      "address_2": "",
      "product_quantity": "490",
      "code_info": "All Instrument Serial Numbers with Software Versions 4.11 and Prior    Model Numbers  AU5811-01, AU5821-01, AU5831-01, AU5841-01,  AU5811-02, AU5821-02, AU5831-02, AU5841-02,  AU5811-03, AU5821-03, AU5831-03, AU5841-03,  AU5811-04, AU5821-04, AU5831-04, AU5841-04,  AU5811-06, AU5821-06, AU5831-06, AU5841-06    Part Numbers  A94906, A94911, A94916, A91921  A94907, A94912, A94917, A94922  A94908, A94913, A94918, A94923  A94909, A94914, A91949, A94924  A94910, A94915, A94920, A94925    Model Numbers and Part Numbers listed above respecitively.",
      "center_classification_date": "20130424",
      "distribution_pattern": "Worldwide Distribution - USA, including Canada and Puerto Rico and  the states of  NJ, TX, CA, UT, KS, MA, NY, MI, GA, VA, IN, WI, IL, OH, NV, NC and PA. and the countries of Australia, Belgium, Czech Republic,  Japan, Germany, Brazil, China, Italy, Ireland, Israel, India, Hong Kong, Malaysia, Netherlands,  Spain, Switzerland, France, Taiwan, Turkey, United Kingdom and Vietnam.",
      "state": "CA",
      "product_description": "AU5800 Clinical Chemistry Analyzer    The Beckman Coulter AU5800 Clinical Chemistry Analyzer is an automated chemistry analyzer that measures analytes in samples, in combination with appropriate reagents, calibrators, quality control (QC) material and other accessories. This system is for in vitro diagnostic use only. Applications include colorimetric, turbidimetric, latex agglutination, homogeneous enzyme immunoassay, and in selective electrode.",
      "report_date": "20130501",
      "classification": "Class II",
      "openfda": {},
      "recalling_firm": "Beckman Coulter Inc.",
      "recall_number": "Z-1167-2013",
      "initial_firm_notification": "Letter",
      "product_type": "Devices",
      "event_id": "64731",
      "termination_date": "20140916",
      "more_code_info": "",
      "recall_initiation_date": "20130320",
      "postal_code": "92821-6232",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "status": "Terminated"
    }
  ]
}