{
  "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": "2026-09-20",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "213699",
      "product_res_number": "Z-1891-2025",
      "event_date_initiated": "2023-02-15",
      "event_date_posted": "2025-05-30",
      "recall_status": "Open, Classified",
      "res_event_number": "96804",
      "product_code": "PQP",
      "pma_numbers": [
        "P170019"
      ],
      "product_description": "FoundationOne Companion Diagnostic (F1CDx)",
      "code_info": "Report Number: ORD-XXXXX04-01;\nNote: The above characters have been redacted to minimize patient information disclosure.",
      "firm_fei_number": "3010679023",
      "recalling_firm": "Foundation Medicine, Inc.",
      "address_1": "150 2nd St",
      "city": "Cambridge",
      "state": "MA",
      "postal_code": "02141-2115",
      "additional_info_contact": "Client Services\n888-988-3639",
      "reason_for_recall": "An incorrect negative claim was identified on the claims page; the device variant information was displayed correctly in the tumor profiling section of the FDA-approved test report.",
      "root_cause_description": "Software design",
      "action": "On February 15, 2023, the physician was alerted of the amended report within the physician's portal. Physician was informed original report included an incorrect negative CDx claim on the claims page; the CDx variant information was displayed correctly in the tumor profiling section of the FDA-approved test report. It is requested that any impact to patient care be forwarded to Foundation Medicine.",
      "product_quantity": "1 unit",
      "distribution_pattern": "US Nationwide distribution in the state of WI.",
      "openfda": {
        "pma_number": [
          "P200016",
          "P210040",
          "P190014",
          "P160018",
          "P160045",
          "P170019",
          "P250027",
          "P240010",
          "P200006",
          "P230011",
          "P190032",
          "P160038",
          "P250036",
          "P210011",
          "P200010",
          "P240040",
          "P260004",
          "P200011"
        ],
        "registration_number": [
          "3003335080",
          "3031598391",
          "3017020141",
          "3007287152",
          "3020703032",
          "3010679023",
          "3003218906",
          "3011104381",
          "3030654068",
          "3012090384",
          "3010889807",
          "3013200421"
        ],
        "fei_number": [
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          "3031598391",
          "3008335090",
          "3007287152",
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          "3010679023",
          "3003218906",
          "3011104381",
          "3030654068",
          "3012090384",
          "3010889807",
          "3013200421"
        ],
        "device_name": "Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System",
        "medical_specialty_description": "Unknown",
        "regulation_number": "",
        "device_class": "3"
      }
    }
  ]
}