{
  "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": "2026-04-15",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "East Walpole",
      "state": "MA",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "76766",
      "recalling_firm": "Siemens Healthcare Diagnostics, Inc",
      "address_1": "333 Coney St",
      "address_2": "N/A",
      "postal_code": "02032-1516",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Worldwide Distribution - US (Nationwide)  Internationally to Australia, Brazil, Canada, Columbia, Cyprus, Japan, Spain",
      "recall_number": "Z-1749-2017",
      "product_description": "Siemens ADVIA Centaur BR assay  Cat No. 09010686, SMN 10340081 (5-pack/250 tests - REF)      BR Assay for CA 27.29 The ADVIA Centaur¿ BR assay is an in vitro diagnostic test for the quantitative serial determination of cancer antigen CA 27.29 in human serum using the ADVIA Centaur¿, ADVIA Centaur¿ XP, and ADVIA Centaur¿ XPT systems. The test is intended for use as an aid in monitoring patients previously treated for Stage II or Stage III breast cancer. Serial testing for CA 27.29 in the serum of patients who are clinically free of disease should be used in conjunction with other clinical methods used for the early detection of cancer recurrence. The test is also intended for use as an aid in the management of breast cancer patients with metastatic disease by monitoring the progression or regression of disease in response to treatment.",
      "product_quantity": "1259 kits",
      "reason_for_recall": "Potential for the ADVIA Centaur Syphilis assay to interfere with the BR (CA 27.29) a assay on the ADVIA Centaur Systems",
      "recall_initiation_date": "20170308",
      "center_classification_date": "20170406",
      "termination_date": "20200122",
      "report_date": "20170412",
      "code_info": "All  lot codes"
    }
  ]
}