{
  "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-3305-2024",
      "product_description": "Atellica IM aTPO Assay, Material Number 10995466 (100 Test) and 10995467 (500 Test)",
      "product_quantity": "9783 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 10995466 (100 Test) - 00630414597935; Material Number 10995467 (500 Test) - 00630414597942;  Lot Number: 26098336 26099336"
    }
  ]
}