{
  "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": "2026-08-15",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "64558",
      "product_res_number": "Z-0295-2008",
      "event_date_initiated": "2007-09-17",
      "event_date_posted": "2008-01-17",
      "recall_status": "Terminated",
      "event_date_terminated": "2012-03-16",
      "res_event_number": "44941",
      "product_code": "JBS",
      "product_description": "Nova 8 Analyzer Calibrator Pack (Catalog/REF # 15196), Nova Biomedical, Waltham, MA",
      "code_info": "Lot Numbers: 610633, 701034, 704053, 707222",
      "firm_fei_number": "1219029",
      "recalling_firm": "Nova Biomedical Corporation",
      "address_1": "200 Prospect St",
      "city": "Waltham",
      "state": "MA",
      "postal_code": "02453-3457",
      "additional_info_contact": "781-894-0800 Ext. 211",
      "reason_for_recall": "Elevated Normalized Ionized Calcium (nCa) and Normalized Ionized Magnesium (nMg) calculated values on patient samples",
      "root_cause_description": "Device Design",
      "action": "Nova issued a Customer Advisory Notice notification by phone\non 9/17/07  to contact customers using a script .  If the facility reports Normalized Ionized Calcium or Normalized Ionized Magnesium, Nova Biomedical will replace existing stock of Nova 8 calibrator packs. If the facility does not report Normalized Ionized Calcium or Normalized\nIonized Magnesium, the account can continue to use the existing lot of calibrator packs.This contact will be documented within the Nova Biomedical complaint database. Intemational Customer Advisory Notice being sent to Nova Biomedical Subsidiariies and Distributors by Federal Express Envelope.The Federal Express envelopes tracking number will be used for delivery confirmation.",
      "product_quantity": "2,999 units",
      "distribution_pattern": "Worldwide, USA, Canada, Argentina, Bangladesh, Bolivia, China, Czech Republic, Denmark, Ecuador, Egypt, Finland, France,Germany,Greece, Hungary, India, Indonesia, Ireland,Italy, Japan, Korea, Mexico, Peru, Poland, Scotland, South Africa, Spain, Sri Lanka. Switzerland, Syria ,Taiwan, Turkey and The United Kingdom",
      "openfda": {
        "device_name": "Timer, General Laboratory",
        "medical_specialty_description": "Clinical Chemistry",
        "regulation_number": "862.2050",
        "device_class": "1",
        "registration_number": [
          "",
          "3045763576",
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        ],
        "fei_number": [
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    }
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}