{
  "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": "2026-08-15",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "85291",
      "product_res_number": "Z-0287-2013",
      "event_date_initiated": "2008-05-01",
      "event_date_posted": "2012-11-13",
      "recall_status": "Terminated",
      "event_date_terminated": "2012-11-13",
      "res_event_number": "53336",
      "product_code": "IDY",
      "product_description": "PT Link Waterbath, Model#PT100.\n\nLab Vision PT Module Plus provides an automated standarized alternative to labor intensive and time consuming dewaxing and epitote retrieval procedures.",
      "code_info": "Catalog #: PT-Module",
      "firm_fei_number": "2022180",
      "recalling_firm": "Dako North America Inc.",
      "address_1": "6392 Via Real",
      "city": "Carpinteria",
      "state": "CA",
      "postal_code": "93013-2921",
      "additional_info_contact": "800-235-5743",
      "reason_for_recall": "Dako is recalling the PT Link Waterbath because of a possible electrical hazard.   Specifically, if the heater pad under the reagent tank becomes wet, it may present an electrical shock hazard when the lid is open.",
      "root_cause_description": "Device Design",
      "action": "The firm, Dako, sent a \"DAKO PT LINK ADVISORY NOTICE\" dated May 1, 2008 to customers who purchased the PT Waterbath along with a customer acknowledgement document informing the users of the potential electrical hazard.  The notice described the product, problem and actions to be taken. The customers were instructed to follow the attached Safety Instructions; place the enclosed warning labels directly on the instrument as shown in the attached instructions and adhere to the warning labels as described. \n\nCustomers with questions were instructed to call Dako Products' Technical Support at (800) 424-0021.",
      "product_quantity": "136 units",
      "distribution_pattern": "Nationwide distribution: USA including states of: AK, CA, CO,  CT, DC, FL, GA, HI, IA, IL IN, KS, KY, MA, MD, MI, MN, MO, NE, NJ, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, and WA.",
      "openfda": {
        "registration_number": [
          "9615162",
          "3043606682",
          "3005787343",
          "1055757",
          "3017299798",
          "3003639866",
          "1067123",
          "3004594181",
          "3008399755",
          "3014165737",
          "3009155756",
          "3038188821",
          "1063851",
          "3016764932",
          "3014498538",
          "8010478",
          "3014680809",
          "3006610913",
          "3003584784",
          "3005953362",
          "3010889707"
        ],
        "fei_number": [
          "1000111022",
          "3043606682",
          "3005787343",
          "1000442352",
          "3004063640",
          "3017299798",
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          "3014498538",
          "3003584784",
          "3014680809",
          "3006610913",
          "3005953362",
          "3010889707"
        ],
        "device_name": "Bath, Flotation, Tissue",
        "medical_specialty_description": "Pathology",
        "regulation_number": "864.3010",
        "device_class": "1"
      }
    }
  ]
}