{
  "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": "North Billerica",
      "state": "MA",
      "country": "United States",
      "classification": "Class I",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "77211",
      "recalling_firm": "Magellan Diagnostics, Inc.",
      "address_1": "101 Billerica Ave Bldg 4",
      "address_2": "N/A",
      "postal_code": "01862-1271",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Worldwide Distribution - US (Nationwide)  Foreign:  AUSTRALIA  AUSTRIA  BOLIVIA  CANADA  CHILE  CHINA  COLOMBIA  DOMINICAN REPUB  ENGLAND  GERMANY  INDIA  UK  ISRAEL  ITALY  JAPAN  KOREA  MALI  MYANMAR  SPAIN  NEPAL  NETHERLANDS  NEW ZEALAND  P.R. CHINA  PANAMA  US  PERU  PHILLIPINES  POLAND  PORTUGAL  REP OF KOSOVO  SOUTH AFRICA  SRI LANKA  USA  SWEDEN  SWITZERLAND  TRINIDAD  UNITED ARAB EMI  VIETNAM",
      "recall_number": "Z-2225-2017",
      "product_description": "Magellan Diagnostics LeadCare and LeadCare II test Kits.     Product Usage:  The LeadCare Blood Lead Test Kit is for in vitro diagnostic use only. The Test Kit is for the quantitative measurement of lead in fresh whole blood. This product is for professional use only. Sensors and Treatment Reagent of the Test Kit are specific for lead only. Contents of this LeadCare Blood Lead Test Kit must only be used with a LeadCare Analyzer and Blood Lead Testing System.",
      "product_quantity": "171,979 kits (total)= 153,447 (US)and 18532 (OUS)",
      "reason_for_recall": "Underestimates the lead concentration of venous blood samples when the sample is analyzed with the LeadCare systems",
      "recall_initiation_date": "20170523",
      "center_classification_date": "20170605",
      "termination_date": "20210708",
      "report_date": "20170614",
      "code_info": "All lot codes"
    }
  ]
}