{
  "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": [
    {
      "country": "United States",
      "city": "Carpinteria",
      "address_1": "1170 Mark Ave",
      "reason_for_recall": "An incorrect HER2 probe concentration was used when producing the probe component (Vial 3) in this kit lot. This has resulted in the HER2 probe concentration being too low.",
      "address_2": "",
      "product_quantity": "31 kits",
      "code_info": "20031683",
      "center_classification_date": "20160629",
      "distribution_pattern": "Worldwide Distribution - US Nationwide in the states of: PA, CA, AL, NC and countries of Austria, Bosnia and Herzegovina, Belgium, Bulgaria, Brazil, Canada, Switzerland, Germany, Spain, France, Greece, Italy, Macedonia,  Qatar, Romania, Serbia, Sweden, and Turkey.",
      "state": "CA",
      "product_description": "Dako HER2 CISH pharmDx Kit, product code: SK 109    Product Usage:  For in vitro diagnostic use. HER2 CISH pharmDx\u001d Kit is intended for dualcolor chromogenic visualization of signals achieved with directly labeled in situ hybridization probes targeting the HER2 gene and centromeric region of chromosome 17. The kit is designed to quantitatively determine HER2 gene status in formalin-fixed, paraffin-embedded breast cancer tissue specimens. Red and blue chromogenic signals are generated on the same tissue section for evaluation under bright field microscopy. The CISH procedure is automated using Dako Autostainer instruments. HER2 CISH pharmDx\u001d Kit is indicated as an aid in the assessment of patients for whom Herceptin\u001d (trastuzumab) treatment is being considered. Results from the HER2 CISH pharmDx\u001d Kit are intended for use as an adjunct to the clinicopathologic information currently used for estimating prognosis in stage II, node-positive breast cancer patients.",
      "report_date": "20160706",
      "classification": "Class II",
      "openfda": {},
      "recalling_firm": "Dako North America Inc.",
      "recall_number": "Z-2099-2016",
      "initial_firm_notification": "Letter",
      "product_type": "Devices",
      "event_id": "74408",
      "termination_date": "20160902",
      "more_code_info": "",
      "recall_initiation_date": "20160610",
      "postal_code": "93013-2918",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "status": "Terminated"
    }
  ]
}