{
  "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": "97209",
      "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": "worldwide distribution - US Nationwide and the countries of Canada, Chile, Japan, Paraguay.",
      "recall_number": "Z-2230-2025",
      "product_description": "RAPIDPoint 500 Systems Wash/Waste Cartridge (4 Pack). Material Number: 10329097.",
      "product_quantity": "1,477 units",
      "reason_for_recall": "Siemens Healthcare Diagnostics is recalling the RAPIDPoint 500 Systems Wash/Waste Cartridge Lot WW/08925 due to a manufacturing error causing positive and negative bias in Ionized Calcium, Potassium, pH, Chloride, pCO2, Glucose and Lactate analytes and their derivatives. Four complaints were filed related to this event that led to Siemens Healthcare Diagnostics identifying an error in the manufacturing process and initiated corrective actions. Use of the affected device may result in errors during QC which could lead to a delay in patient treatment. If bias generated from this issue is not caught during QC erroneous results may cause temporary or medically reversible adverse health consequences to patients.",
      "recall_initiation_date": "20250626",
      "center_classification_date": "20250731",
      "report_date": "20250806",
      "code_info": "Material Number: 10329097. GTIN Number: 00630414482163. Lot Number: WW/08925. Expiration Date: 12/03/2025.",
      "more_code_info": ""
    }
  ]
}