{
  "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": "2026-08-13",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "189083",
      "product_res_number": "Z-0083-2022",
      "event_date_initiated": "2021-09-03",
      "event_date_created": "2021-10-08",
      "recall_status": "Open, Classified",
      "res_event_number": "88607",
      "product_code": "OWD",
      "pma_numbers": [
        "P150047"
      ],
      "product_description": "cobas EGFR Mutation Test v2-Somatic gene mutation detection system\nCatalog Number :07248563190",
      "code_info": "All lot numbers",
      "firm_fei_number": "2243471",
      "recalling_firm": "Roche Molecular Systems, Inc.",
      "address_1": "1080 US Highway 202 S 1080 US Highway 202",
      "city": "S Branchburg",
      "state": "NJ",
      "postal_code": "08876-3733",
      "additional_info_contact": "SAME\n908-253-7200",
      "reason_for_recall": "False Mutation Detected results for the exon 20 insertion (Ex20Ins) mutation when using the cobas EGFR Mutation Test v2, may lead to inappropriate treatment",
      "root_cause_description": "Under Investigation by firm",
      "action": "Roche issued Urgent Medical Device Correction letter on 9/3/21 via UPS Ground. Letter states reason for recall, health risk and action to take:\nFollow the cobas DNA Sample Preparation Kit (catalog number 05985536190) IFU for sample input\nwith regard to the number of FFPET sections and DNA concentration. Follow the cobas cfDNA Sample\nPreparation Kit (catalog number 07247737190) IFU for plasma samples.\n\" If an Ex20Ins Mutation Detected result is generated with the cobas EGFR Mutation Test v2, you must\nconfirm the result with another method (e.g., sequencing or other PCR-based tests).\n\" Consider reviewing results generated since May 2021. Amivantamab was approved by the U.S. Food and\nDrug Administration (FDA) for NSCLC patients with EGFR Ex20Ins on May 21, 2021. Test result reports\nwith Ex20Ins Mutation Detected may be considered for confirmatory testing using sequencing or other\nPCR-based tests, upon the discretion of a CAP/CLIA laboratory director.\n\" Consult with your facility physician and/or pathologist to determine any clinical implications specific to your\npatients.\n\" Complete all sections of the enclosed faxback form (TP-01381) and fax it to 1-855-208-4038 or email it to Roche8166@sedgwick.com.\n\" File this UMDC for future reference.\n\nPlease contact the Roche Support Network Customer Support Center, 24 hours a day, seven days a week at\n1-800-526-1247 if you have questions about the information contained in this UMDC",
      "product_quantity": "507 US; 6,676 ex- US",
      "distribution_pattern": "Worldwide distribution - US Nationwide distribution and the countries of Canada,\nUK, Poland, Spain, Italy, Sweden, Greece, Denmark, Norway, Netherlands, France, Czech Republic, Belgium, Austria, Slovakia, Hungary, Switzerland, Lithuania, Slovenia.\nSerbia, North Macedonia, Myanmar, Lebanon, Russia, Croatia, Morocco, Kazakhstan, Dominican Republic, Israel, El Salvador, Vietnam, Malaysia, Taiwan, China, Japan, Hong Kong, Korea, Brazil, Philippines, Thailand, Chile, Colombia, Singapore, Argentina, Australia, India, Uruguay, Ecuador, Panama, Costa Rica, Pakistan, Peru, Indonesia, New Zealand.",
      "openfda": {
        "pma_number": [
          "P220005",
          "P150044",
          "P150047",
          "P120019",
          "P170005",
          "P190001",
          "P170041",
          "P110030",
          "P140023",
          "P160040",
          "P110027",
          "P120014",
          "P180043",
          "P190004",
          "P190026",
          "P120022",
          "P200014",
          "P110020",
          "P210002"
        ],
        "registration_number": [
          "3005248192",
          "3004013603",
          "3004530258",
          "3003795116",
          "3010791816",
          "3014173060",
          "3004141078",
          "3016838963",
          "2243471",
          "9610126",
          "9610529"
        ],
        "fei_number": [
          "3005248192",
          "3002806559",
          "3004013603",
          "3004530258",
          "3002806560",
          "3003795116",
          "3010791816",
          "3014173060",
          "3004141078",
          "3016838963",
          "2243471"
        ],
        "device_name": "Somatic Gene Mutation Detection System",
        "medical_specialty_description": "Unknown",
        "regulation_number": "",
        "device_class": "3"
      }
    }
  ]
}