{
  "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": "2026-08-20",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "160634",
      "product_res_number": "Z-0676-2018",
      "event_date_initiated": "2017-11-29",
      "event_date_created": "2018-02-21",
      "recall_status": "Terminated",
      "event_date_terminated": "2018-08-22",
      "res_event_number": "78832",
      "product_code": "LKV",
      "pma_numbers": [
        "P920048"
      ],
      "product_description": "Rapid for the TLiIQ(R) System, HOLOGIC(R), Catalog number: 01200",
      "code_info": "K6030, L6010, M6007, M6032, A7024, A7056, B7017, B7042, B7057, C7053, D7008, D7043, E7058, E7082",
      "firm_fei_number": "2024800",
      "recalling_firm": "Hologic, Inc.",
      "address_1": "1240 Elko Dr",
      "city": "Sunnyvale",
      "state": "CA",
      "postal_code": "94089-2212",
      "additional_info_contact": "Kathy Chester\n408-745-0975 Ext. 128",
      "reason_for_recall": "Rapid fFN cassettes were manufactured with material (A137 ascites) from a new supplier (SDIX). The products were distributed to customers before FDA approved the change to use the material from SDIX.",
      "root_cause_description": "Mixed-up of materials/components",
      "action": "Hologic initiated the recall on Wednesday, November 29, 2017. The method of notification was via overnight FedEx.",
      "product_quantity": "165 kits",
      "distribution_pattern": "United States (US), Guam (GU), Japan (JP)",
      "openfda": {
        "pma_number": [
          "P920048"
        ],
        "registration_number": [
          "2029372",
          "2024800",
          "3006330030",
          "3005360469"
        ],
        "fei_number": [
          "3005670738",
          "2024800",
          "3006330030",
          "1000306617"
        ],
        "device_name": "Enzyme Immunoassay, Fetal Fibronectin",
        "medical_specialty_description": "Unknown",
        "regulation_number": "",
        "device_class": "3"
      }
    }
  ]
}