{
  "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": "Tarrytown",
      "state": "NY",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "95259",
      "recalling_firm": "Siemens Healthcare Diagnostics, Inc.",
      "address_1": "511 Benedict Ave",
      "address_2": "N/A",
      "postal_code": "10591-5005",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Worldwide distribution - US Nationwide.",
      "recall_number": "Z-3304-2024",
      "product_description": "ADVIA Centaur aTPO Assay, Material Number 10630886 (100 Test) and 10630887 (500 Test)",
      "product_quantity": "5622 kits",
      "reason_for_recall": "Positive bias in patient results at and below the cut-off of 60 U/mL with the lots listed in the table below when compared to alternate lots on the Atellica IM analyzer.",
      "recall_initiation_date": "20240821",
      "center_classification_date": "20240927",
      "report_date": "20241009",
      "code_info": "UDI-DI:  Material Number 10630886 (100 Test) - 00630414587837; Material Number 10630887 (500 Test) - 00630414587844;  Lot Number: 26053337 26054337 26051337 26052337"
    }
  ]
}