{
  "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,
      "total": 1
    }
  },
  "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-0350-2023",
      "product_description": "Trinity Biotech HbA1c (GHb) Contorls Kit, 500uL (Levels I & II), REF 01-04-0020, Part number 05-01-0040B, A1c analysis",
      "product_quantity": "182 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.  Additionally, per the firm, 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": "UDI/DI 0539151674808, Lot 12161",
      "more_code_info": ""
    }
  ]
}