{
  "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": "2026-07-08",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Ongoing",
      "city": "Norwood",
      "state": "MA",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "96539",
      "recalling_firm": "Siemens Healthcare Diagnostics Inc",
      "address_1": "2 Edgewater Dr",
      "address_2": "",
      "postal_code": "02062-4637",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Domestic: Nationwide Distribution; Foreign: Albania, Argentina, Australia, Austria, Bahrain, Bangladesh, Belgium, Bolivia, Bosnia, Brazil, Cambodia, Canada, Canary Islands, Chile, China, Colombia, Croatia, Ecuador, Estonia, France, Germany, Ghana, Greece, Guadeloupe, Guatemala, Hong Kong, Hungary, Iceland, India, Indonesia, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kuwait, Lithuania, Malaysia, Mali, Martinique, Mexico, Morocco, Netherlands, New Caledonia, New Zealand, Nigeria, Oman, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Reunion, Romania, Russian Federation, San Marino, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Vietnam.",
      "recall_number": "Z-1684-2025",
      "product_description": "epoc BGEM BUN Test Card (25 pk) for the epoc Blood Analysis System; Siemens Material Number (SMN): 10736515; epoc Software Version & Sensor Configuration: epoc Host SW v3.41.2, epoc NXS SW v4.14.9 & 4.14.11, Sensor Configuration 45.n.",
      "product_quantity": "264,252 units",
      "reason_for_recall": "The occurrence of discrepant high pH results in samples introduced with higher injection volumes with epoc sensor configuration 45.n.",
      "recall_initiation_date": "20250319",
      "center_classification_date": "20250429",
      "report_date": "20250507",
      "code_info": "Siemens Material Number (SMN): 10736515; Udi-DI: 00809708121860; Lot Numbers: All lot numbers with prefix (xx) 02 or 12; epoc Software Version and Senor Configuration: epoc Host SW V3.41.2, epoc NXS SW v4.14.9 & 4.14.11, Sensor Configuration 45.n.",
      "more_code_info": ""
    }
  ]
}