{
  "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": "Waltham",
      "state": "MA",
      "country": "United States",
      "classification": "Class III",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "75708",
      "recalling_firm": "PerkinElmer Health Sciences, Inc.",
      "address_1": "940 Winter St",
      "address_2": "N/A",
      "postal_code": "02451-1457",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "CA, CO, NY, WA  Foreign:  Austria, Bolivia, Bosnia , Sweden, Norway, Netherlands,  Japan, Great Britain,",
      "recall_number": "Z-0779-2017",
      "product_description": "DELFIA hFSH kit. In Vitro Diagnostic for the determination of hFSH in serum",
      "product_quantity": "79 kits",
      "reason_for_recall": "A DELFIA hFSH kit lot failed real time stability testing. The real time stability data demonstrated a decrease in hFSH concentrations between -4.8% to -11.3% for control sera.  The -11.3% bias was observed at an hFSH target concentration of 101 IU/L.  The change observed in the serum samples within the range 1.76 \u0013 67.0 IU/L hFSH averaged -2.9%.  The reference range of the assay spans 0.60 to 98.0 IU/L.",
      "recall_initiation_date": "20161116",
      "center_classification_date": "20161216",
      "termination_date": "20170705",
      "report_date": "20161228",
      "code_info": "Lot Number: 646091"
    }
  ]
}