{
  "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": "2026-04-01",
    "results": {
      "skip": 0,
      "limit": 1,
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    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Kansas City",
      "state": "MO",
      "country": "United States",
      "classification": "Class III",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "91054",
      "recalling_firm": "Primus Corporation dba Trinity Biotech",
      "address_1": "4231 E 75th Ter",
      "address_2": "",
      "postal_code": "64132-2059",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Turkey, India, Romania, Thailand, Vietnam, S. Korea, Peru, Pakistan Austria, UAE, Chile, Italy.",
      "recall_number": "Z-0349-2023",
      "product_description": "A. MENARINI diagnostics Hb 9210 PREMIER, LEVEL1, LEVEL II, Hemoglobin A1c Controls for hemoglobin A1c Assay, REF 45052, part number 05-01-0926, A1c analysis",
      "product_quantity": "340 kits",
      "reason_for_recall": "The Control Level I material value was showing results exceeding the upper limit of the acceptable range after a period of three (3) months.  The unacceptable Control Level 1 value results in the Analyzer generating an error code which stops further testing and nullifies associated patient samples, resulting in a delay in patient results and a potential delay in therapeutic modifications.",
      "recall_initiation_date": "20211005",
      "center_classification_date": "20221201",
      "termination_date": "20230809",
      "report_date": "20221207",
      "code_info": "Lot 12161",
      "more_code_info": ""
    }
  ]
}