{
  "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": "2026-08-20",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "176246",
      "product_res_number": "Z-0535-2020",
      "event_date_initiated": "2019-08-08",
      "event_date_created": "2019-11-22",
      "recall_status": "Terminated",
      "event_date_terminated": "2021-07-19",
      "res_event_number": "83729",
      "product_code": "PQP",
      "pma_numbers": [
        "P170019"
      ],
      "product_description": "FoundationOne CDx test report",
      "code_info": "Model/Lot/Serial Number: QRF150009.01 , QRF150228.01 , QRF150108.01 , QRF149795.01, QRF150117.01 , QRF150247.01 , QRF149634.01 , QRF128938.01",
      "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": "Nicole Green\n617-418-2200",
      "reason_for_recall": "Identified potential false positive MSI-H on the test reports provided to the physicians.",
      "root_cause_description": "Under Investigation by firm",
      "action": "Firm informed the physicians via phone stating:\n\n1. They had recently received may have an incorrect MSI-H result which could be erroneous due to  a possible false positive and to not use the MSI analyte to prescribe treatment. \n\n2. The prescribing physicians were also told that an amended report designating MSI as undetermined would be issued immediately. \n\n3. The physicians were asked if any treatment plan using the MSI result had been started and all confirmed that no treatment plan utilizing the MSI analyte had been used. \n\n4. They were also informed of the availability of FMI Medical Affairs staff physicians to provide additional information or answer any follow questions that they may have.",
      "product_quantity": "8 reports",
      "distribution_pattern": "MA, NC,IN, OH, GA",
      "openfda": {
        "pma_number": [
          "P160018",
          "P240010",
          "P250036",
          "P190032",
          "P210040",
          "P200006",
          "P170019",
          "P250027",
          "P210011",
          "P230011",
          "P200016",
          "P240040",
          "P200010",
          "P160045",
          "P200011",
          "P160038",
          "P260004",
          "P190014"
        ],
        "registration_number": [
          "3031598391",
          "3010889807",
          "3013200421",
          "3003335080",
          "3020703032",
          "3007287152",
          "3017020141",
          "3010679023",
          "3003218906",
          "3030654068",
          "3012090384",
          "3011104381"
        ],
        "fei_number": [
          "3031598391",
          "3010889807",
          "3016560486",
          "3013200421",
          "3003335080",
          "3007287152",
          "3010679023",
          "3003218906",
          "3030654068",
          "3012090384",
          "3011104381",
          "3008335090"
        ],
        "device_name": "Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System",
        "medical_specialty_description": "Unknown",
        "regulation_number": "",
        "device_class": "3"
      }
    }
  ]
}