{
  "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": {
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  "results": [
    {
      "cfres_id": "166939",
      "product_res_number": "Z-0064-2019",
      "event_date_initiated": "2018-06-13",
      "event_date_created": "2018-10-03",
      "recall_status": "Terminated",
      "event_date_terminated": "2019-03-18",
      "res_event_number": "80916",
      "product_code": "KPA",
      "product_description": "Leica Biosystems HistoCore SPECTRA ST, Slide Stainer, Automated\n\nProduct Usage:  The intended use of this device is a stainer for laboratory applications and intended for the preparation of histological and cytological specimens.",
      "code_info": "Serial Numbers: 70-78, 111-112, 120-175",
      "firm_fei_number": "3000210133",
      "recalling_firm": "Leica Microsystems, Inc.",
      "address_1": "1700 Leider Ln",
      "city": "Buffalo Grove",
      "state": "IL",
      "postal_code": "60089-6622",
      "additional_info_contact": "800-225-8867",
      "reason_for_recall": "These devices have an incorrect specification against safety standard ISO61010-1. Should a single fault error occur, a mains wire can contact a metal plate which is accessible to the user. This could lead to mains power on the metal plate resulting in hazardous voltage to the user.",
      "root_cause_description": "Device Design",
      "action": "On approximately 06/13/2018 sent a Field Action Notices to consignees.  Instructions included to make arrangements with their Leica Service Engineer to correct affected devices, ensure all appropriate personnel are made aware of the recall, and complete and return the Field Action Notice Return Response Form to confirm receipt and understanding of the recall notice.",
      "product_quantity": "67 units",
      "distribution_pattern": "Distributed nationwide to AZ, CA, CO, KS, MA, MH, MO, NJ, OH, WI.  \n\nDistributed worldwide to CANADA, CHINA, GERMANY, GREAT BRITAIN, JAPAN, SWITZERLAND",
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        "device_name": "Slide Stainer, Automated",
        "medical_specialty_description": "Pathology",
        "regulation_number": "864.3800",
        "device_class": "1",
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