{
  "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": "214979",
      "product_res_number": "Z-2521-2025",
      "event_date_initiated": "2025-06-17",
      "event_date_posted": "2025-09-04",
      "recall_status": "Open, Classified",
      "res_event_number": "97258",
      "product_code": "PQP",
      "pma_numbers": [
        "P240010"
      ],
      "product_description": "MI Cancer Seek REF MSC000\nUDI Code: (01)00860008613325(21)H5HJHDSXF\n\nMI Cancer Seek is a single-site assay intended to provide tumor mutational profiling to be used by qualified healthcare professionals in accordance with professional oncology guidelines for cancer patients with previously diagnosed solid malignant neoplasms.",
      "code_info": "Catalog Number: MSC000\nUDI Code: (01)00860008613325(21)H5HJHDSXF\nSerial Number: H5HJHDSXF",
      "firm_fei_number": "3008335090",
      "recalling_firm": "CARIS LIFE SCIENCES",
      "address_1": "350 W Washington St Fl 4 350 W Washington St",
      "address_2": "Fl 4",
      "city": "Tempe",
      "state": "AZ",
      "postal_code": "85288-1495",
      "additional_info_contact": "Peggy Carter\n351-220-3883",
      "reason_for_recall": "Due to an incorrect test results provided that indicated the incorrect drug therapy recommendation",
      "root_cause_description": "Software design",
      "action": "On 07/14/2025, the firm emailed an \"URGENT: MEDICAL DEVICE RECALL\" Letter its customer that inform them that an incorrect CDx report was issued on April 14, 2025 with the wild-type KRAS/NRAS results with VECTIBIX (panitumumab) listed as a therapeutic option.  The potential cause of the issue occurred due to two unanticipated events occurring in succession within the operational aspect of the report generation software processes of MI Cancer Seek.  These two events in succession resulted in a failing file.\n\nCustomer was provided with an amended report and instructed to:\n-Review the report paying careful attention to the amended CDx report with the header \"MI Cancer Seek\" which changes the wild-type KRAS/NRAS result  Detected  to wild-type KRAS/NRAS result to  Not Detected  and the KRAS G12C variant listed in the  Other Alterations and Biomarkers Identified  section towards the bottom of the page. The new CDx report also includes the banner,  Findings did not yield any biomarker results with Companion Diagnostic (CDx) claims .\n\nFor questions, contact Regulatory Affairs at 351-220-3883 Monday thru Friday 8:00 AM to 5:00 PM Mountain Standard Time or email Pcarter@carisls.com.  In addition Caris Customer Support +1-888-979-8669",
      "product_quantity": "1",
      "distribution_pattern": "U.S. Nationwide distribution in the state of NY.",
      "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": [
          "3003335080",
          "3031598391",
          "3008335090",
          "3007287152",
          "3016560486",
          "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"
      }
    }
  ]
}