{
  "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": "2026-09-17",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 2
    }
  },
  "results": [
    {
      "cfres_id": "216767",
      "product_res_number": "Z-0577-2026",
      "event_date_initiated": "2022-11-08",
      "event_date_posted": "2025-11-21",
      "recall_status": "Open, Classified",
      "res_event_number": "97854",
      "product_code": "PQP",
      "pma_numbers": [
        "P170019"
      ],
      "product_description": "FoundationOne CDx (F1CDx), RAL-0003 version 31.0",
      "code_info": "F1CDX - RAL-0003 version 31.0;\nTest Numbers: ORD-XXXX425-01 (JP), ORD-XXX5703-01 (JP), ORD-XXXX467-01 (JP), ORD-XXXX474-01 (JP), ORD-XXXX460-01 (JP), ORD-XXXX612-01 (JP), ORD-XXXX484-01 (JP), ORD-XXXX440-01 (JP), ORD-XXXX665-01 (JP), ORD-XXXX699-01 (JP), ORD-XXXX546-01 (JP), ORD-XXXX689-01 (JP), ORD-XXXX695-01 (JP), ORD-XXXX451-01 (JP), ORD-XXXX455-01 (JP), ORD-XXXX476-01 (JP), ORD-XXXX481-01 (JP), ORD-XXXX477-01 (JP), ORD-XXXX509-01 (SG), ORD-XXXX511-01 (SG), ORD-XXXX985-01 (US), ORD-XXXX071-01 (US), ORD-XXXX731-01 (US), ORD-XXXX999-01 (US), ORD-XXXX069-01 (US), ORD-XXXX352-01 (US), ORD-XXXX993-01 (US), ORD-XXXX294-01 (US), ORD-XXXX822-01 (US), ORD-XXXX210-01 (US), ORD-XXXX683-01 (US), ORD-XXXX979-01 (US), ORD-XXXX413-01 (US), ORD-XXXX843-01 (US), ORD-XXXX316-01 (US), ORD-XXXX960-01 (US), ORD-XXXX001-01 (US), ORD-XXXX804-01 (US), ORD-XXXX600-01 (US), ORD-XXXX940-01 (US), ORD-XXXX367-01 (US), ORD-XXXX771-01 (US), ORD-XXXX169-01 (US), ORD-XXXX296-01 (US), ORD-XXXX290-01 (US), ORD-XXXX320-01 (US), ORD-XXXX255-01 (US), ORD-XXXX897-01 (US), ORD-XXXX377-01 (US), ORD-XXXX252-01 (US), ORD-XXXX475-01 (US), ORD-XXXX545-01 (US), ORD-XXXX690-01 (US), ORD-XXXX378-01 (US), ORD-XXXX740-01 (US), ORD-XXX1300-01 (US), ORD-XXXX470-01 (US), ORD-XXXX424-01 (US), ORD-XXXX115-01 (US).",
      "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": "888-988-3639",
      "reason_for_recall": "Reports were sent to customers without the companion diagnostic (CDx) Claims Page. Claims pages\nwere distributed via amended reports within 7 days of the issue occurrence.",
      "root_cause_description": "Under Investigation by firm",
      "action": "On 08 November 2022, Notification Emails with amended reports were emailed to customers.  The Foundation Medicine's Medical Affairs team email alerted its customer to a recently issued amended report [Date of Amended Report] for one of your patients [Patient Order Number].\n\nThis Amended Report has been issued to update the report template to include the correct [FoundationOneLiquid CDx/FoundationOneCDx] reporting template, including the associated Claims page. Please note that other aspects of this report may have changed from the previous version to reflect the most up-to-date reporting information.\n\nIf you have questions about this information, please do not hesitate to call 1-888-988-3639 or email: client.services@foundationmedicine.com. Please confirm receipt of this email or Foundation Medicine can also follow-up with a phone call.",
      "product_quantity": "59 units (39 US, 20 OUS)",
      "distribution_pattern": "US Nationwide distribution to states of: AL, AZ, CA, FL, GA, IL, IN, KS, KY, ME, MN, MO, MS, MT, NC, NJ, NV, NY, OK, PA, PR, SD, TN, TX, UT, VA, WA, WI, WV.\n\nOUS International to countries: Japan, Singapore.",
      "openfda": {
        "pma_number": [
          "P240010",
          "P190032",
          "P210011",
          "P250036",
          "P200011",
          "P190014",
          "P230011",
          "P200016",
          "P170019",
          "P200006",
          "P200010",
          "P250027",
          "P160045",
          "P240040",
          "P210040",
          "P160018",
          "P160038",
          "P260004"
        ],
        "registration_number": [
          "3012090384",
          "3003335080",
          "3010889807",
          "3010679023",
          "3013200421",
          "3030654068",
          "3017020141",
          "3007287152",
          "3003218906",
          "3011104381",
          "3020703032",
          "3031598391"
        ],
        "fei_number": [
          "3012090384",
          "3016560486",
          "3003335080",
          "3010889807",
          "3010679023",
          "3013200421",
          "3030654068",
          "3007287152",
          "3003218906",
          "3011104381",
          "3008335090",
          "3031598391"
        ],
        "device_name": "Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System",
        "medical_specialty_description": "Unknown",
        "regulation_number": "",
        "device_class": "3"
      }
    }
  ]
}