{
  "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": "2026-08-20",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "66207",
      "product_res_number": "Z-0725-2008",
      "event_date_initiated": "2007-11-02",
      "event_date_posted": "2008-02-16",
      "recall_status": "Terminated",
      "event_date_terminated": "2008-12-09",
      "res_event_number": "45815",
      "product_code": "CGL",
      "k_numbers": [
        "K070068"
      ],
      "product_description": "Nova - EZ CHEM Control Solution P/N 9612, Nova Biomedical, Waltham, MA  02454",
      "code_info": "Lot  Numbers: 4207225241 and 4207261241",
      "firm_fei_number": "1219029",
      "recalling_firm": "Nova Biomedical Corporation",
      "address_1": "200 Prospect St",
      "city": "Waltham",
      "state": "MA",
      "postal_code": "02453",
      "additional_info_contact": "Paul W. MacDonald\n781-894-0800 Ext. 211",
      "reason_for_recall": "Incorrect Results - Creatinine results were lower than the laboratory reference method.",
      "root_cause_description": "Device Design",
      "action": "Nova Biomedical issued an Urgent: Medical Device Recall notification letter to consignees dated November 19, 2007. The letter addressed the issues with the product(s) and requested that if users had any remaining stock that it must be returned.  The firm also provided a Customer Response form to be returned.  Questions concerning this recall will be addressed by Gina Vogelsberg at 1-800-544-4624 or by email at gvogelsberg@ezem.com.",
      "product_quantity": "300 units",
      "distribution_pattern": "Nationwide Distribution, including the state of NY",
      "openfda": {
        "k_number": [
          "K261039",
          "K070068",
          "K973292",
          "K991727",
          "K051968",
          "K113726",
          "K171059",
          "K903034"
        ],
        "device_name": "Electrode, Ion Based, Enzymatic, Creatinine",
        "medical_specialty_description": "Clinical Chemistry",
        "regulation_number": "862.1225",
        "device_class": "2",
        "registration_number": [
          "3005643513",
          "3012817228",
          "2245578",
          "1219029",
          "3013513377",
          "3023162659",
          "3002807968",
          "3007490412",
          "3004959793",
          "3004193489",
          "3011979858",
          "3006198300"
        ],
        "fei_number": [
          "3005643513",
          "3012817228",
          "2245578",
          "1219029",
          "3013513377",
          "3023162659",
          "3002807968",
          "3007490412",
          "3004959793",
          "3004193489",
          "3011979858",
          "3006198300"
        ]
      }
    }
  ]
}