{
  "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": "2026-04-22",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "country": "United States",
      "city": "Norwood",
      "address_1": "2 Edgewater Dr",
      "reason_for_recall": "Software defect, where either an Above Assay Range or an inaccurate value could potentially be reported, in the Stratus CS Acute Care Diagnostics System regarding TestPak calibration and quality control (QC) status when a TestPak is due to expire within 48 hours.",
      "address_2": "",
      "product_quantity": "977 units",
      "code_info": "All software versions and serial numbers",
      "center_classification_date": "20160811",
      "distribution_pattern": "Worldwide Distribution -- USA, U.A.E.,  Algeria,  Armenia, Australia, Austria, Bangladesh, Belgium, Bosnia Herzeg., Botswana, Canada, Colombia, Croatia, Czech Republic, Denmark, Finland, France, Germany, Greece, India, Ireland,   Italy, Japan, Libya, Lithuania, Malaysia, Mexico, Namibia, P.R. China, Poland, Portugal, Romania, Saudi Arabia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Turkey, U.A.E., and United Kingdom.",
      "state": "MA",
      "product_description": "Stratus¿ CS STAT Fluorometric Analyzer-microprocessor-controlled instrument  that measures certain analytes in body fluids for in vitro diagnostic use. Assays include ~hCG, CRP, CKMB, cTNI, D-Dimer, Myoglobin, and pBNP.  SMN: 10444834, 10453531",
      "report_date": "20160817",
      "classification": "Class II",
      "openfda": {},
      "recalling_firm": "Siemens Healthcare Diagnostics Inc",
      "recall_number": "Z-2525-2016",
      "initial_firm_notification": "Letter",
      "product_type": "Devices",
      "event_id": "74534",
      "termination_date": "20181129",
      "more_code_info": "",
      "recall_initiation_date": "20160622",
      "postal_code": "02062-4637",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "status": "Terminated"
    }
  ]
}