{
  "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": "2026-09-12",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "191885",
      "product_res_number": "Z-0750-2022",
      "event_date_initiated": "2022-01-27",
      "event_date_created": "2022-03-11",
      "recall_status": "Open, Classified",
      "res_event_number": "89533",
      "product_code": "JTW",
      "product_description": "Panther Fusion Extraction Reagent-X, REF PRD-04477, For use with Panther Fusion System, IVD, Rx only, Contents: FCR-X Fusion Capture reagent-X 4 EA, FER-X Fusion Enhancer Reagent-X (Lithium Hydroxide Solution) 4 EA",
      "code_info": "Panther Fusion Extraction Reagent-X - Lot Numbers: 281375 and 291829\n\nComponents included within the kit:\nPanther Fusion Capture Reagent-X (FCR-X) - Lot Numbers: 281330 and 290312\nPanther Fusion Enhancer Reagent-X (FER-X) - Lot Numbers281332 and 290331",
      "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": "Hologic Technical Support\n1888-410-8250",
      "reason_for_recall": "Failed stability specifications for reagent kits that may result in false negative test results.",
      "root_cause_description": "Unknown/Undetermined by firm",
      "action": "on 2/3/22 Hologic issued a \"Urgent: Medical Device Recall Notification\" via FedEx. In addition to informing consignees about the recall, the firm ask consignees to take the following action:\n\n1. Immediately discontinue use of the lot of Panther Fusion Extraction Reagent-X kits and respective components\n\n2.  Immediately check their inventory and segregate the Panther Fusion Extraction Reagent-X kit lot\n\n3.  The number of kits shipped to the site is identified on the accompanying Customer Response Form (CRF).\n\n4.  Return the completed CRF to Hologic Technical Support, even if none of the kits remaining in the inventory.\n\n5. If any of the specified kits remain in inventory (whether unopened or partial kits containing used reagent), to contact Hologic Technical Support. To destroy the segregated inventory After returning the completed CRF.\n\n6. After returning the completed CRF, please destroy the segregated inventory. \n\nWhen this documentation is complete, please fax the CRF to Hologic Technical Support using this fax number: +1 858 410 8250. Alternatively, you can scan the document(s) and email to Hologic Technical Support at molecularsupport@hologic.com \n\n8. If you have any questions or concerns regarding this recall notification, please contact Hologic Technical Support at +1 88 484 474 or +1 858410 8511 during the hours of 5 AM PDT - 5 PM PDT, or by e-mail at molecularsupport@hologic.com",
      "product_quantity": "264 kits",
      "distribution_pattern": "Worldwide distribution - US Nationwide distribution in the states of AR, CA, CT, FL, GA, ID, IL, IN, MA, MD, ME, MI, NJ, NV, NY, OH, OR, PA, TN, TX, UT, VA, WA, WI, WV, District of Columbia and the countries of Canada, Australia, Belgium, Netherlands, China, Italy, Germany, Sweden.",
      "openfda": {
        "k_number": [
          "K843359",
          "K882580",
          "K843341",
          "K831579",
          "K780440",
          "K983244",
          "K811284",
          "K961148",
          "K022874",
          "K121039",
          "K791924",
          "K760054",
          "K934894",
          "K790366",
          "K895187",
          "K772207",
          "K772209",
          "K993161",
          "K771058",
          "K872325",
          "K811283",
          "K802563",
          "K840719",
          "K840991",
          "K772205",
          "K772210",
          "K840990",
          "K872326",
          "K904773",
          "K843173",
          "K061301",
          "K013819",
          "K770957",
          "K791953",
          "K802023",
          "K830250",
          "K840968",
          "K770683",
          "K772206",
          "K772208",
          "K823443",
          "K760458",
          "K803298"
        ],
        "registration_number": [
          "3010155648",
          "3010132111",
          "3002444944",
          "1216735",
          "3015441043",
          "9681465",
          "3001124136",
          "3010407203",
          "1924669",
          "3011689956",
          "2649614",
          "1220477",
          "3011088743",
          "8021914",
          "3016587486",
          "3043226252",
          "3013517171",
          "2243072",
          "1917413",
          "3012494290",
          "3013557562",
          "3002806470",
          "3036773433",
          "9610126",
          "1420054"
        ],
        "fei_number": [
          "3002807113",
          "3010155648",
          "3010132111",
          "3002444944",
          "1216735",
          "3015441043",
          "3001124136",
          "3010407203",
          "1924669",
          "3011689956",
          "2649614",
          "1220477",
          "3011088743",
          "3002806559",
          "3016587486",
          "3043226252",
          "3013517171",
          "3002806332",
          "2243072",
          "1917413",
          "3012494290",
          "3013557562",
          "3002806470",
          "3036773433",
          "1420054"
        ],
        "device_name": "System, Transport, Aerobic",
        "medical_specialty_description": "Microbiology",
        "regulation_number": "866.2900",
        "device_class": "1"
      }
    }
  ]
}