{
  "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": "2026-05-06",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "country": "United States",
      "city": "Branchburg",
      "address_1": "1080 Us Highway 202 S",
      "reason_for_recall": "During the real-time stability testing for the cobas KRAS Mutation Test on the commercial lot PO6778, it was identified that the kit was just within specifications for the codon 61 peak height ratio, and that the kit has trended towards the upper specification limit at the 6 month time point but did passed the 6 month stability testing.  The kit is labeled for 9 months shelf life stability.  The d",
      "address_2": "",
      "product_quantity": "264 kits to 13 EU countries; 2 kits to Canada and 33 kits to 11 countries in the Rest of the World",
      "code_info": "05852170190; Lot P06778",
      "center_classification_date": "20120808",
      "distribution_pattern": "Worldwide Distribution - including the countries of Austria, Belgium, Czech Republic, Denmark, Germany, Italy, Luxemburg, Netherlands, Poland, Slovakia, Slovenia, Spain, United Kingdom, Canada, Chile, Greenland, Hong Kong, Israel, Malaysia, New Zealand, Philippines, S. Africa, Switzerland, Taiwan and Turkey.",
      "state": "NJ",
      "product_description": "Cobas KRAS Mutation Test for In Vitro Diagnostic Use    Product Usage:  Usage:  The Cobas KRAS Mutation Test, for use with the Cobas 4800 System, is a real-time PCR test 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 cancer (CRC).",
      "report_date": "20120815",
      "classification": "Class III",
      "openfda": {},
      "recalling_firm": "Roche Molecular Systems, Inc.",
      "recall_number": "Z-2159-2012",
      "initial_firm_notification": "E-Mail",
      "product_type": "Devices",
      "event_id": "62500",
      "termination_date": "20130716",
      "more_code_info": "",
      "recall_initiation_date": "20120224",
      "postal_code": "08876-3733",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "status": "Terminated"
    }
  ]
}