{
  "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": "2026-08-15",
    "results": {
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      "limit": 1,
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    {
      "cfres_id": "196608",
      "product_res_number": "Z-0349-2023",
      "event_date_initiated": "2021-10-05",
      "event_date_posted": "2022-12-01",
      "recall_status": "Terminated",
      "event_date_terminated": "2023-08-09",
      "res_event_number": "91054",
      "product_code": "JPK",
      "k_numbers": [
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      "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",
      "code_info": "Lot 12161",
      "firm_fei_number": "1931251",
      "recalling_firm": "Primus Corporation dba Trinity Biotech",
      "address_1": "4231 E 75th Ter",
      "city": "Kansas City",
      "state": "MO",
      "postal_code": "64132-2059",
      "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.",
      "root_cause_description": "Nonconforming Material/Component",
      "action": "The firm sent an Urgent Filed Safety Notice their consignees on 10/05/2021 by mail.  The notice explained the issue, risk and requested the destruction of of the affected devices.",
      "product_quantity": "340 kits",
      "distribution_pattern": "Turkey, India, Romania, Thailand, Vietnam, S. Korea, Peru, Pakistan Austria, UAE, Chile, Italy.",
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