{
  "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 II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "77695",
      "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": "Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit",
      "distribution_pattern": "Worldwide - US Nationwide distribution and the countries of:  COLOMBIA, CANADA, THAILAND, INDIA, UAE, AUSTRALIA, GERMANY, CANADA, SOUTH AFRICA, SPAIN, NEW ZEALAND, KOREA",
      "recall_number": "Z-3035-2017",
      "product_description": "LeadCare II Blood Lead Test Kit, containing LeadCare II Lead Controls    Product Usage:  IVD test kit for the detection of lead in blood. The kit consists of sensors, treatment reagent, lead controls (two levels), heparinized capillary tubes and plungers, transfer droppers and a calibration button. The LeadCare II Lead Controls packaged in the kit lots listed in #2 below are the subject of this recall (Field Correction) action.",
      "product_quantity": "12,931 kits",
      "reason_for_recall": "LeadCare II Test Kits controls out of range",
      "recall_initiation_date": "20160120",
      "center_classification_date": "20170815",
      "termination_date": "20180221",
      "report_date": "20170823",
      "code_info": "Lot # :1507N  Exp Date: 1/27/17;  Lot # :1508N  Exp Date: 2/27/17;  Lot # :1510N  Exp Date: 4/19/17;  Lot # :1511M  Exp Date: 5/3/17  Lot # :1511N  Exp Date: 5/17/17  Lot # :1512M  Exp Date: 6/2/17"
    }
  ]
}