{
  "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-0153-2014",
      "product_description": "ISE REF Valve, Part No. MU7638 for the AU480, AU680, and AU5800 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": "AU480, Item Code:  N3151200  N3151300  N3151400  N3151500  N3151600  N3151700  N3151800  N3151900  N3659600  N3659700  N3659900  N3660000  N3660200  N3660400  N3660600  N3660800  N3912500    AU480 OPA, Item Code:  B11803  N3152300  N3152400  N3152500  N3152600  N3912600    AU680, Item Code:  B12184  B12185  B12187  B12188  N3147100  N3147200  N3147300  N3147400  N3147500  N3148100  N3149800  N3153300  N3153700  N3153800  N3154000  N3658100  N3662100  N3662200  N3662400  N3662900  N3663000  N3910100  N3910400  N3910500  N3910800  N3910900  N3911200  N3911300  N3911900    AU680 OPA:   B11474  N3148300  N3148600  N3148700  N3150500  N3912700      AU5800 OPA, Item Code:   A94927  A94928  A94929  A94930  N9028030"
    }
  ]
}