{
  "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": "2026-04-15",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Indianapolis",
      "state": "IN",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "75366",
      "recalling_firm": "Roche Diagnostics Operations, Inc.",
      "address_1": "9115 Hague Rd",
      "address_2": "N/A",
      "postal_code": "46256-1025",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide.",
      "recall_number": "Z-0395-2017",
      "product_description": "Tina-Quant Hemoglobin A1c Gen. 2  Hemoglobin A1c test  Catalog number 04528123190 / 05401640190",
      "product_quantity": "4976",
      "reason_for_recall": "Roche Diagnostics has confirmed elevated QC and patient sample recovery for individual  Tina-quant¿ Hemoglobin A1c Gen.2 and Tina-quant Hemoglobin A1cDx Gen.2 cassettes/bottles.  This issue occurred over multiple lots. Single cassettes/bottles of the reagents are affected.  The issue can lead to erroneously high HbA1c results. If a patient with known diabetes is affected,  an erroneously high HbA1c result might lead to therapeutic consequences, such as therapy escalation  (introduction of another oral antidiabetic medication or insulin) or increase of the dosage. This can  further lead to an increased risk of hypoglycemia. Considering the unreliable detectability of the issue,  relevant medical risk for the patient cannot entirely be excluded.",
      "recall_initiation_date": "20161004",
      "center_classification_date": "20161111",
      "termination_date": "20170605",
      "report_date": "20161123",
      "code_info": "Not applicable"
    }
  ]
}