{
  "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": "221172",
      "product_res_number": "Z-2951-2026",
      "event_date_initiated": "2026-06-10",
      "event_date_posted": "2026-08-14",
      "recall_status": "Open, Classified",
      "res_event_number": "99268",
      "product_code": "PQP",
      "pma_numbers": [
        "P200006",
        "P170019"
      ],
      "product_description": "Hamilton Microlab STAR Liquid Handler; Protocol Configuration Tool (PCT) v2.0.0. Used to conduct F1CDx and F1LCDx.",
      "code_info": "Software Version: Protocol Configuration Tool (PCT) v2.0.0; Equipment ID: 100071, 100213, 100355, 102281, 103047, 104154, 104201, 104202, 104204, 104205, 104224, 104503, 104504, 104562, 104885, 105961, 106497, 00016, 00487, 00488, 00489, 00490, 00817, 00491, 00492, 00854, 01173, 01174, 01785, 01337, 01596, 01993.",
      "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": "Software issue that can cause an increase in spontaneous software closures.",
      "root_cause_description": "Software design",
      "action": "An URGENT MEDICAL DEVICE RECALL NOTIFICATION dated 6/10/26 was emailed to consignees. Consignees were instructed to review the impacted equipment list and verify that the PCT V2.0.1 software version has been installed. If software hasn't been updated FMI will follow up to assist with installation. The recall notice is to be forwarded to anyone in the facility or outside the organization that needs to be informed. The notification is to be retained with laboratory records. Questions can be directed to Foundation Medicine at 888-988-3639 or QACTAdverseEventReporting@foundationmedicine.com.",
      "product_quantity": "32 units",
      "distribution_pattern": "US Nationwide distribution in the states of MA & NC.",
      "openfda": {
        "pma_number": [
          "P250036",
          "P160038",
          "P230011",
          "P190032",
          "P200016",
          "P250027",
          "P210040",
          "P200011",
          "P170019",
          "P160045",
          "P200006",
          "P160018",
          "P200010",
          "P240040",
          "P240010",
          "P190014",
          "P260004",
          "P210011"
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        "registration_number": [
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        "fei_number": [
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          "3007287152",
          "3012090384",
          "3031598391",
          "3016560486"
        ],
        "device_name": "Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System",
        "medical_specialty_description": "Unknown",
        "regulation_number": "",
        "device_class": "3"
      }
    }
  ]
}