{
  "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": "2026-08-20",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "151081",
      "product_res_number": "Z-0779-2017",
      "event_date_initiated": "2016-11-16",
      "event_date_posted": "2016-12-16",
      "recall_status": "Terminated",
      "event_date_terminated": "2017-07-05",
      "res_event_number": "75708",
      "product_code": "CGJ",
      "k_numbers": [
        "K862043"
      ],
      "product_description": "DELFIA hFSH kit. In Vitro Diagnostic for the determination of hFSH in serum",
      "code_info": "Lot Number: 646091",
      "firm_fei_number": "3006159931",
      "recalling_firm": "PerkinElmer Health Sciences, Inc.",
      "address_1": "940 Winter St",
      "city": "Waltham",
      "state": "MA",
      "postal_code": "02451-1457",
      "additional_info_contact": "781-663-6900",
      "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  67.0 IU/L hFSH averaged -2.9%.  The reference range of the assay spans 0.60 to 98.0 IU/L.",
      "root_cause_description": "Other",
      "action": "PerkinElmer initiated  recall on November 16, 2016, delivered to the end customer by email facilitated through the PerkinElmer Technical Support group located in Akron Ohio. Technical Support will be asked to make sure the customers receive the Recall Letter and understand the recommended actions.\nUsers asked to inspect inventory, discontinue use destroy the kits and complete the Response Forms and Destruction.Replacement kits will shipped.",
      "product_quantity": "79 kits",
      "distribution_pattern": "CA, CO, NY, WA\nForeign:\nAustria, Bolivia, Bosnia , Sweden, Norway, Netherlands,  Japan, Great Britain,",
      "openfda": {
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        "device_name": "Radioimmunoassay, Follicle-Stimulating Hormone",
        "medical_specialty_description": "Clinical Chemistry",
        "regulation_number": "862.1300",
        "device_class": "1"
      }
    }
  ]
}