{
  "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 III",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "63539",
      "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": "FAX",
      "distribution_pattern": "Nationwide Distribution",
      "recall_number": "Z-0429-2013",
      "product_description": "Minotrol 16, Model Numbers: 2043748, 2043752, 2043756, Lot Number: MX090(Levels: Low, Normal, and High).    Minotrol 16 is a tri-level control intended for in vitro diagnostic use in monitoring the accuracy and precision on HORIBA Medical hematology blood cell counters using HORIBA Medical reagents. Minotrol 16 is an in vitro diagnostic reagent composed of human erythrocytes, mammalian leukocytes, and platelets in a plasma-like fluid with preservatives. Minotrol 16 is a stable material that provides a means of determining the accuracy and precision of hematology blood cell counters. It is handled in the same manner as a patient specimen. The assay tables are determined on validated instruments using the appropriate reagents",
      "product_quantity": "22,954",
      "reason_for_recall": "HORIBA Medical Irvine Technical Support received reports from some customers that have experienced high recover values for Hemoglobin when using Minotrol 16 lot #MX090 (Level High).  Customer communication was sent 10/01/2010.",
      "recall_initiation_date": "20120914",
      "center_classification_date": "20121121",
      "termination_date": "20130422",
      "report_date": "20121128",
      "code_info": "Model Numbers: 2043748, 2043752, 2043756, Lot Number: MX090(Levels Low, Normal, and High)."
    }
  ]
}