{
  "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,
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  },
  "results": [
    {
      "cfres_id": "175008",
      "product_res_number": "Z-0046-2020",
      "event_date_initiated": "2018-12-10",
      "event_date_posted": "2019-10-04",
      "recall_status": "Terminated",
      "event_date_terminated": "2021-04-28",
      "res_event_number": "83383",
      "product_code": "NOT",
      "k_numbers": [
        "K141109"
      ],
      "product_description": "Aperio CS2 CE IVD scanner instrument, scanner part #23CS100CE.",
      "code_info": "Serial numbers 5899, 5902, and 5986.",
      "firm_fei_number": "3006791373",
      "recalling_firm": "Leica Biosystems Imaging, Inc.",
      "address_1": "1360 Park Center Dr",
      "city": "Vista",
      "state": "CA",
      "postal_code": "92081-8300",
      "additional_info_contact": "Robert Browning\n760-304-6211",
      "reason_for_recall": "The incorrect sensor was used in the assembly of the camera in the scanner instrument which can potentially generate whole slide images that impact analysis algorithm results, as well as potentially impact the visual appearance of whole slide images.",
      "root_cause_description": "Component design/selection",
      "action": "The consignees were notified beginning on 12/10/2018 via letter delivered by email.",
      "product_quantity": "3 devices",
      "distribution_pattern": "There was no U.S. distribution.  Foreign distribution was made to South Korea and the United Kingdom.",
      "openfda": {
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          "K080910",
          "K260755",
          "K121350"
        ],
        "device_name": "Microscope, Automated, Image Analysis, Operator Intervention",
        "medical_specialty_description": "Hematology",
        "regulation_number": "864.1860",
        "device_class": "2",
        "registration_number": [
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          "2028492",
          "9615060"
        ],
        "fei_number": [
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          "3009505338",
          "1000125183"
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      }
    }
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}