{
  "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": 70
    }
  },
  "results": [
    {
      "cfres_id": "158900",
      "product_res_number": "Z-0027-2018",
      "event_date_initiated": "2017-09-15",
      "event_date_created": "2017-10-18",
      "recall_status": "Terminated",
      "event_date_terminated": "2020-07-30",
      "res_event_number": "78216",
      "product_code": "NSU",
      "k_numbers": [
        "K132251"
      ],
      "product_description": "Panther(R) System, Catalog Number 902615, For Use with Hologic Assays, For In Vitro Diagnostic Use",
      "code_info": "Serial Number 20900001124",
      "firm_fei_number": "2024800",
      "recalling_firm": "Hologic, Inc",
      "address_1": "10210 Genetic Center Dr",
      "city": "San Diego",
      "state": "CA",
      "postal_code": "92121-4362",
      "additional_info_contact": "Kathy Chester\n858-410-8444",
      "reason_for_recall": "An incorrect incubator was installed on one Panther System which potentially led to incorrect Aptima Combo 2(R) assay (AC2) results.",
      "root_cause_description": "Employee error",
      "action": "The customer was notifed of the potential incorrect results via a phone call on September 15, 2017.\nA customer letter was sent on September 18, 2017.\n The notification letter requests the customer to re-test any negative Aptima Combo 2 assay results tested between July 13, 2017  Aug 30, 2017.",
      "product_quantity": "1 unit",
      "distribution_pattern": "Indiana",
      "openfda": {
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        "device_name": "Instrumentation For Clinical Multiplex Test Systems",
        "medical_specialty_description": "Clinical Chemistry",
        "regulation_number": "862.2570",
        "device_class": "2"
      }
    }
  ]
}