{
  "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": "66253",
      "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 countries of  Canada, Vietnam, Zambia, and Zimbabwe.",
      "recall_number": "Z-0152-2014",
      "product_description": "ISE REF Valve, Part No. MU3226 for the AU400, AU640, AU2700, and AU5400 Chemistry Analyzer.    Automated chemistry analyzers that measures analytes in samples.",
      "product_quantity": "4584 units total (1173 units in US)",
      "reason_for_recall": "The recall was initiated because Beckman Coulter has confirmed that some AU Clinical Chemistry Analyzer ISE units can experience premature ISE REF (Reference) valve failure.  Premature valve failure can be detected by the presence of air bubbles in the ISE REF solution tubing on the ISE unit.  If air bubbles are present, accuracy of the ISE test results may be affected.",
      "recall_initiation_date": "20130909",
      "center_classification_date": "20131105",
      "termination_date": "20140930",
      "report_date": "20131113",
      "code_info": "AU400, Item Code:  5427200  5427400  5427600  N1254000  N1254200  N1254400  N1254600  N1255000  n1255200  N1257400  N2571700  N2571800  N3658500  N3658700  N3658800  N3659000  N3659400  N3912300  N9020723  N9020724      AU400 OPA, Item Code:  5427300  5427900  N1257700      AU640, Item Code:  5900100  5900400  5900600  N1255700  N1255900  N1256100  N1256300  N1256700  N2572800  N3660900  N3661200  N3661300  N3661500  N3661700  N3661900    AU640 OPA, Item Code:  590220  5902400  A92928  A92929    AU2700, Item Code:  5996300  5996500  5998100  N1465100  N1465300  N1465500  N1465600  N1465900  N1466100  N1815200  N1815600  N1815700  N1816200  N1816300  N3155800  N3155900  N3156000  N3156100  N3156200  N3156300  N3156400  N3156500  N3156600  N3156800  N3157000  N3663100  N3663300  N3663500  N3663600  N3663800  N3663900  N3664100  N3664300  N3664500  N3664700  N3664900  N3878600    AU2700 OPA, Item Code:  5996100  N3156700  N9025844    AU5400 OPA, Item Code:   6196400  6196500  6196700  N1257900  N1258000  N3666000  N3877100  N3877200  N3877300  N3877600  N3877700"
    }
  ]
}