{
  "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": "2026-04-08",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "country": "United States",
      "city": "Newark",
      "address_1": "500 Gbc Dr Ms 514",
      "reason_for_recall": "An increase in the number of failed calibration events or negative bias with Quality Control (QC) and patient samples when using Dimension Vista LOCI 8 Calibrator lot 7CD076 to calibrate Estradiol (E2) Assay.",
      "address_2": "PO BOX 6101",
      "product_quantity": "989 (681 USA/308 OUS)",
      "code_info": "CATALOG #(s):  KC646  Lot 7CD076- UDI# (01)00842768026492(10)7CD076(17)20180401",
      "center_classification_date": "20180326",
      "distribution_pattern": "Worldwide Distribution: US (nationwide) and countries of: Austria, Belgium, Canada, Denmark, France, Germany, Italy, Netherlands, Slovakia, Spain and Switzerland.",
      "state": "DE",
      "product_description": "Dimension Vista System LOCI 8 CALIBRATOR     The LOCI 8 Calibrator is an in vitro diagnostic product for the calibration of follicle stimulating hormone (FSH), luteinizing hormone (LH), prolactin (PRL), and estradiol (E2) methods on the Dimension Vista System.",
      "report_date": "20180404",
      "classification": "Class II",
      "openfda": {},
      "recalling_firm": "Siemens Healthcare Diagnostics, Inc.",
      "recall_number": "Z-1184-2018",
      "initial_firm_notification": "Letter",
      "product_type": "Devices",
      "event_id": "79412",
      "termination_date": "20200608",
      "more_code_info": "",
      "recall_initiation_date": "20171109",
      "postal_code": "19702-2466",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "status": "Terminated"
    }
  ]
}