{
  "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": "2026-08-13",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "183752",
      "product_res_number": "Z-0099-2021",
      "event_date_initiated": "2020-09-02",
      "event_date_created": "2020-10-13",
      "recall_status": "Terminated",
      "event_date_terminated": "2022-09-28",
      "res_event_number": "86465",
      "product_code": "NDY",
      "k_numbers": [
        "K071388",
        "K081875"
      ],
      "product_description": "GENTIAN Cystatin C Calibrator and Calibrator Kit, for the following models:\n\n1. Gentian C E, Cystatin C Calibrator, 1 x 1 mL, REF 1012, UDI: (01)07090038460092\n2. Gentian C E Calibrator Kit, 6 x 1 mL, REF 1051, UDI:  (01)07090038460108\n3. Gentian  C E, BCI Ref: A52763, Cystatin C calibrator Kit, 6 x 1 mL, REF 1051, (01)17090038460037\n4. Gentian C E, Cystatin C Calibrator,  1 x 1 mL, REF 8012 (Not distributed in US)",
      "code_info": "Lot numbers #s: 1905415,1904404,1904403,1809403",
      "firm_fei_number": "3006801241",
      "recalling_firm": "Gentian AS",
      "address_1": "Bjornasveien 5 5 bjornasveien",
      "city": "Moss",
      "country": "Norway",
      "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.",
      "root_cause_description": "Under Investigation by firm",
      "action": "Gentian AS  issued a \"Field Safety Notice\" letter on September 2, 2020 concerning the removal of the Gentian Cystatin C Calibrator and Calibrator Kit. In addition, to informing consignees about the recall the firm asked consignees to take the following actions:\n\n1. Discontinue use of the affected lots listed in this Field Safety Notice\n2. Please inform Gentian of remaining stock of the affected lots numbers given in this Field\nSafety Notice.\n3. Share this notification with other relevant personnel in your organization and affected\ncustomers\n4. Please sign and return this document by e-mail to confirm that this notification of withdrawal has been received and understood.",
      "product_quantity": "107 calibrator kits",
      "distribution_pattern": "US: MN,  VA, KS,",
      "openfda": {
        "k_number": [
          "K242585",
          "K041878",
          "K081875",
          "K063647",
          "K171072",
          "K003503",
          "K072166",
          "K080384",
          "K063351",
          "K041627",
          "K093960",
          "K181082",
          "K080811",
          "K093680",
          "K083906",
          "K072270",
          "K080662",
          "K111664",
          "K093137",
          "K071388",
          "K141143",
          "K161817"
        ],
        "registration_number": [
          "3004493545",
          "2032900",
          "9612316",
          "9614373",
          "3002809144",
          "2084025",
          "9610099",
          "9610126",
          "3003423869",
          "8031673",
          "1827821",
          "9681753",
          "3003795116",
          "3013059683",
          "3012471076",
          "3009189893",
          "3005333358",
          "1000403749",
          "2432235",
          "3006801241",
          "3006198300",
          "9610529",
          "3005529799",
          "9610806"
        ],
        "fei_number": [
          "3004493545",
          "3002808328",
          "3002808340",
          "3000303338",
          "3002809144",
          "2084025",
          "3002806560",
          "3003423869",
          "2967",
          "3002806778",
          "1827821",
          "3002806559",
          "3004445302",
          "3003795116",
          "3013059683",
          "3012471076",
          "3009189893",
          "3001644026",
          "3005333358",
          "1000403749",
          "2432235",
          "3006801241",
          "3006198300",
          "3005529799"
        ],
        "device_name": "Test, Cystatin C",
        "medical_specialty_description": "Clinical Chemistry",
        "regulation_number": "862.1225",
        "device_class": "2"
      }
    }
  ]
}