{
  "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": "2026-04-29",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Branchburg",
      "state": "NJ",
      "country": "United States",
      "classification": "Class III",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "70058",
      "recalling_firm": "Roche Molecular Systems, Inc.",
      "address_1": "1080 Us Highway 202 S",
      "address_2": "N/A",
      "postal_code": "08876-3733",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Foreign Distributed.",
      "recall_number": "Z-0999-2015",
      "product_description": "cobas 4800 KRAS AMP/DET 24T CE-IVD Mutation Test; CE-IVD 5852170190.    Intended for the identification of mutations in codons 12,13 and 61 of the KRAS Gene in DNA derived from formalin-fixed paraffin-embedded human colorectal and non-small cell lung cancer tissues.",
      "product_quantity": "660 pieces",
      "reason_for_recall": "cobas KRAS Mutation Kit T10786 is generating invalid results for the Mutant Control and/or KRAS Calibrator.",
      "recall_initiation_date": "20141218",
      "center_classification_date": "20150120",
      "termination_date": "20170208",
      "report_date": "20150128",
      "code_info": "Lots T10786  T13091, T15435, T15475, T14777, and W00389"
    }
  ]
}