{
  "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": "2026-09-05",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "219260",
      "product_res_number": "Z-1927-2026",
      "event_date_initiated": "2026-03-20",
      "event_date_posted": "2026-04-22",
      "recall_status": "Open, Classified",
      "res_event_number": "98625",
      "product_code": "PQP",
      "pma_numbers": [
        "P170019"
      ],
      "product_description": "Sequencing Agent SEQ0067, component of FoundationOne CDx (F1CDx)",
      "code_info": "Model Number: SEQ0067. Lot Numbers: 24346, 24386, 24488.",
      "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": "Clarke Madigan\n617-418-2200",
      "reason_for_recall": "Possible increase in phasing, potentially resulting in false-positive BARD1 splice site indel artifact variants",
      "root_cause_description": "Under Investigation by firm",
      "action": "Foundation Medicine notified consignees via emailed letter on about 03/20/2026.  Consignees were instructed to review, complete, sign and return the provided business reply form and review inventory and identify affected units, quarantine those units, and return to the FMI Boston Warehouse quarantine location via standard laboratory transfer practices. Consignees were also instructed to forward the notification to anyone within the facility that should be informed and if there is any impact that requires this notice to be forwarded to another facility, including facilities where units of inventory may have been transferred, contact that facility and provide them with this letter.  Consignees were asked to retain the letter with laboratory records made aware that Foundation Medicine will work with the supplier of these components to replace impacted units.",
      "product_quantity": "163 units",
      "distribution_pattern": "US Nationwide distribution in the states of Massachusetts and North Carolina.",
      "openfda": {
        "pma_number": [
          "P250036",
          "P160038",
          "P230011",
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          "P200016",
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          "P200011",
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          "P160045",
          "P200006",
          "P160018",
          "P200010",
          "P240040",
          "P240010",
          "P190014",
          "P260004",
          "P210011"
        ],
        "registration_number": [
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          "3030654068",
          "3013200421",
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          "3010889807",
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        ],
        "device_name": "Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System",
        "medical_specialty_description": "Unknown",
        "regulation_number": "",
        "device_class": "3"
      }
    }
  ]
}