{
  "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": "Irvine",
      "state": "CA",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "63838",
      "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": "Nationwide Distribution including CA, OK, NY, FL, AZ, NY, VA, and TX.",
      "recall_number": "Z-0633-2013",
      "product_description": "PENTRA C200, Part Number: A11A01629.    The Pentra C200 system is a fully automated chemistry analyzer using colorimetry, turbidmetry and potentiometry technologies. It is mostly dedicated to in vitro diagnostic analyses based on homogeneous samples such as serum, plasma and uring.",
      "product_quantity": "384 units",
      "reason_for_recall": "Horiba Medical is recalling the ABX PENTRA AST CP because during the AST application validation on the Pentra C200 using an Audit Systems linearity kit, it was determined that two higher values for AST  (expected at 800 U/L and 1000 U/L) were recorded at 280 and 199 U/L without alarm.",
      "recall_initiation_date": "20121010",
      "center_classification_date": "20130103",
      "termination_date": "20130912",
      "report_date": "20130109",
      "code_info": "Lot number: 00456-4108"
    }
  ]
}