{
  "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": "2026-09-05",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "221169",
      "product_res_number": "Z-2937-2026",
      "event_date_initiated": "2026-05-18",
      "event_date_posted": "2026-08-12",
      "recall_status": "Open, Classified",
      "res_event_number": "99266",
      "product_code": "PIG",
      "k_numbers": [
        "K232761"
      ],
      "product_description": "ProNephro AKI (NGAL) Reagent Kit (100 tests). IVD Acute Kidney Injury Test System.",
      "code_info": "Model number: ST101UB / 08787174 190; GTIN code: 5711435000156; Lot-number: 04909125 and 04912125.",
      "firm_fei_number": "3010739981",
      "recalling_firm": "Bioporto Diagnostics A/S",
      "address_1": "Tuborg Havnevej 15, St 15 tuborg havnevej",
      "address_2": "St",
      "city": "Hellerup",
      "country": "Denmark",
      "additional_info_contact": "Jennifer Zondermann\n1-617-6942918",
      "reason_for_recall": "The use of a non-validated rework process for assay reagents which could lead to missed diagnosis of renal disease, inappropriate treatment decisions, or inappropriate monitoring of renal disease in\nintended users.",
      "root_cause_description": "Nonconforming Material/Component",
      "action": "A Quality Notification dated 6/3/26 was sent to consignees via email notifying them of the recall. Consignees in the US are to coordinate replacement of devices. ROW Consignees are to scrap unopened kits in accordance with local requirements and request replacements.",
      "product_quantity": "400 units",
      "distribution_pattern": "Worldwide - The affected product distribution included the United States and the countries of European Union, Chile, and Hong Kong. No affected product was distributed to Canada; however, Health Canada was notified because the product is registered in Canada.",
      "openfda": {
        "k_number": [
          "K210793",
          "K232761",
          "DEN130031",
          "K153165",
          "K171482"
        ],
        "device_name": "Acute Kidney Injury Test System",
        "medical_specialty_description": "Clinical Chemistry",
        "regulation_number": "862.1220",
        "device_class": "2",
        "registration_number": [
          "8020790",
          "3010739981"
        ],
        "fei_number": [
          "1000611339",
          "3010739981"
        ]
      }
    }
  ]
}