{
  "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": "2026-08-27",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "192206",
      "product_res_number": "Z-0896-2022",
      "event_date_initiated": "2021-12-21",
      "event_date_created": "2022-04-07",
      "recall_status": "Terminated",
      "event_date_terminated": "2024-02-12",
      "res_event_number": "89680",
      "product_code": "JKD",
      "product_description": "C-Peptide ELISA : IVD measurement of C-Peptide in serum, plasma (EDTA-, heparin- or citrate plasma) and urine.\nCatalog # EIA-1293",
      "code_info": "Lot# / Expiration dates:\t\t\n20K061 / 2022-06-30\n20K071 / 2022-07-31\n20K081 / 2022-08-31",
      "firm_fei_number": "2245285",
      "recalling_firm": "DRG International, Inc.",
      "address_1": "841 Mountain Ave",
      "city": "Springfield",
      "state": "NJ",
      "postal_code": "07081-3437",
      "additional_info_contact": "SAME\n973-564-7555",
      "reason_for_recall": "ODs of the standards too low(< 0.6 ODmax)\nmay cause invalid runs, delayed patient results are possible",
      "root_cause_description": "Under Investigation by firm",
      "action": "DRG issued letter via email on 12/28/21. Letter states reason for recall, health risk and \nAction to be taken by distributors and end-users:\nPlease check your inventory for the respective lot, stop using these kits immediately and\npromptly quarantine these products.\nOnly if you faced above mentioned issue of SO OD <1.2, please ask for replacement of the kits that were affected and provide your data. All unused kits of the affected lot will be replaced.Please reply immediately upon checking your stock/use to this notice to confirm. All replies should be received at once OR by January 7th, 2022.\nWe sincerely apologize for the inconvenience this may have caused you and/or your Customer. Reply to email: qa@drg-international.com and copy  drgsupport@drginternational.com.",
      "product_quantity": "3 Kits",
      "distribution_pattern": "NY",
      "openfda": {
        "k_number": [
          "K810718",
          "K842267",
          "K896420",
          "K812288",
          "K833396",
          "K820666",
          "K854066",
          "K943767",
          "K951848",
          "K812689"
        ],
        "registration_number": [
          "3022178699",
          "3004434309",
          "3002806944",
          "2432235",
          "1036362",
          "9612316",
          "9610746",
          "3002694097",
          "8031673",
          "3009491259",
          "2029372",
          "2133982",
          "2245285",
          "9610126",
          "3002809144",
          "3014325803",
          "3002800697",
          "3006198300",
          "3009984016",
          "3005542422",
          "3007111389",
          "2020726",
          "9610240",
          "3027977508",
          "3005948789",
          "1222302",
          "3005529799",
          "1319681",
          "3017894300",
          "2032839",
          "3005333358",
          "3017019647",
          "3003741796",
          "3009335633",
          "3003356736",
          "3008198807"
        ],
        "fei_number": [
          "3022178699",
          "3002806557",
          "3004434309",
          "3002806944",
          "3002808328",
          "3004185580",
          "2432235",
          "1036362",
          "3002694097",
          "3009491259",
          "2967",
          "1000306617",
          "1000136573",
          "2245285",
          "3000717645",
          "3002808212",
          "3002809144",
          "3014325803",
          "3002800697",
          "3006198300",
          "3009984016",
          "3005542422",
          "1000121039",
          "3007111389",
          "2020726",
          "3027977508",
          "3005948789",
          "3002806559",
          "3005529799",
          "3017894300",
          "3005333358",
          "3017019647",
          "3003741796",
          "3009335633",
          "3003356736",
          "3008198807"
        ],
        "device_name": "Radioimmunoassay, C-Peptides Of Proinsulin",
        "medical_specialty_description": "Clinical Chemistry",
        "regulation_number": "862.1135",
        "device_class": "1"
      }
    }
  ]
}