{
  "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": "Irvine",
      "address_1": "34 Bunsen",
      "reason_for_recall": "This recall was initiated because some customers were experiencing an alarm during Creatinine calibration \"REAG RANGE HIGH\". This alarm caused the calibration to fail and prevented the user from using the Creatinine assay.",
      "address_2": "",
      "product_quantity": "8,503 units",
      "code_info": "Model Number Creatinine Part # A11A01868, Lot Numbers: 203273706, 203273707, 203273808, 203273709.",
      "center_classification_date": "20121114",
      "distribution_pattern": "Nationwide Distribution",
      "state": "CA",
      "product_description": "ABX PENTRA Creatinine 120 CP, Model Number Creatinine Part # A11A01868, Lot Numbers: 203273706, 203273707, 203273808, 203273709.   The ABX PENTRA Creatinine 120 CP is an in vitro diagnostic assay for the quantitative determination of creatinine in human serum, plasma and urine based on a kinetic method using alkaline picrate (Jaffe method). It is composed of a 27 ml monoreagent cassette. Reagent is a chemical solution with additives.    ABX PENTRA Creatinine 120 CP reagent, with associated calibrator and controls, is a diagnostic reagent for quantitative in vitro determination of Creatinine in human serum, plasma and urine based on a kinetic method using alkaline picrate (Jaffe method). Creatinine measurements are used in the diagnosis and treatment of renal diseases, in monitoring renal dialysis, and as a calculation basis for measuring other urine analytes. This reagent is intended for use on the ABX PENTRA 400 Clinical Chemistry Analyzer.",
      "report_date": "20121121",
      "classification": "Class III",
      "openfda": {},
      "recalling_firm": "Horiba Instruments, Inc dba Horiba Medical",
      "recall_number": "Z-0289-2013",
      "initial_firm_notification": "Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit",
      "product_type": "Devices",
      "event_id": "63536",
      "termination_date": "20121129",
      "more_code_info": "",
      "recall_initiation_date": "20120914",
      "postal_code": "92618-4210",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "status": "Terminated"
    }
  ]
}