{
  "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": "Moss",
      "state": "N/A",
      "country": "Norway",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "86465",
      "recalling_firm": "Gentian AS",
      "address_1": "Bjornasveien 5",
      "address_2": "N/A",
      "postal_code": "N/A",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "US: MN,  VA, KS,",
      "recall_number": "Z-0099-2021",
      "product_description": "GENTIAN Cystatin C Calibrator and Calibrator Kit, for the following models:    1. Gentian C E, Cystatin C Calibrator, 1 x 1 mL, REF 1012, UDI: (01)07090038460092  2. Gentian C E Calibrator Kit, 6 x 1 mL, REF 1051, UDI:  (01)07090038460108  3. Gentian  C E, BCI Ref: A52763, Cystatin C calibrator Kit, 6 x 1 mL, REF 1051, (01)17090038460037  4. Gentian C E, Cystatin C Calibrator,  1 x 1 mL, REF 8012 (Not distributed in US)",
      "product_quantity": "107 calibrator kits",
      "reason_for_recall": "The firm has identified lots of calibrators that have shown to measure incorrect high values over time compared to the assigned values when released for distribution. This could result in higher Cystatin C values measured in patients.",
      "recall_initiation_date": "20200902",
      "center_classification_date": "20201013",
      "termination_date": "20220928",
      "report_date": "20201021",
      "code_info": "Lot numbers #s: 1905415,1904404,1904403,1809403"
    }
  ]
}