{
  "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-0632-2013",
      "product_description": "ABX PENTRA AST CP, Part Number: A11A01629.    The ABX Pentra AST CP reagent is a diagnostic reagent for quantitative in vitro determination of Aspartate Amino Transferase (AST) in serum or plasma by colorimetry.",
      "product_quantity": "66886 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"
    }
  ]
}