{
  "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": "2026-04-29",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Irvine",
      "state": "CA",
      "country": "United States",
      "classification": "Class III",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "66209",
      "recalling_firm": "Horiba Instruments, Inc dba Horiba Medical",
      "address_1": "34 Bunsen",
      "address_2": "N/A",
      "postal_code": "92618-4210",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Worldwide Distribution - USA including the country of Canada.",
      "recall_number": "Z-2280-2013",
      "product_description": "ABX PENTRA Calcium CP Reagent, Model # A11A01633    Calcium plays an essential role in many cell functions: intracellularly in muscle contraction and glycogen metabolism, extracellularly, in bone mineralization, in blood coagulation and in transmission of nerve impulses. Calcium is present in plasma in three forms: free, bound to proteins or complexed with anions as phosphate, citrate and bicarbonate. Under physiological conditions, calcium balance is determined by the relationship between calcium intake and calcium absorption and excretion. Urinary excretion is an important determinant of calcium retention in the body. Decreased total calcium levels can be associated with diseases of the bone apparatus (especially osteoporosis), kidney diseases (especially under dialysis), defective intestinal absorption and hypoparathyroidism. Increased total calcium can be measured in hyperparathyroidism, malignant diseases with metastases and sarcoidosis. Calcium measurements also help in monitoring of calcium supplementation mainly in the prevention of osteoporosis.",
      "product_quantity": "2,658 units   ( 1240 US  1418 OUS )",
      "reason_for_recall": "HORIBA Medical is informing all PENTRA 200 and PENTRA 400 customers of a potential for reporting  incorrect calcium results when using the ABX PENTRA CALCIUM CP reagent.",
      "recall_initiation_date": "20130906",
      "center_classification_date": "20130926",
      "termination_date": "20140823",
      "report_date": "20131002",
      "code_info": "Lot/Serial #(s): 014664503"
    }
  ]
}