{
  "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": "192103",
      "product_res_number": "Z-0963-2022",
      "event_date_initiated": "2022-01-20",
      "event_date_created": "2022-04-21",
      "recall_status": "Open, Classified",
      "res_event_number": "89645",
      "product_code": "GKZ",
      "k_numbers": [
        "K190898"
      ],
      "product_description": "The Sight OLO device is a computer vision based platform for blood analysis. The platform\ncombines computer-vision algorithms for image processing to identify and quantify blood\ncomponents (e.g., red blood cells) and their characteristics (e.g., cell volume) in an\nautomated fashion. Using dedicated staining, the proposed platform provides complete\nblood count analysis. The Sight OLO is a compact device, designed to be automated and\nsimple to operate, to enable rapid testing and analysis. The Sight OLO consists of a\nscanning and analyzing device and a CBC test kit, including disposable cartridges and\nsample preparation tools. The disposable cartridge containing the blood sample is loaded\ninto the device through the loading slot. The device is operated through the touch screen\ninterface. The Sight OLO provides complete blood count information with 5-part differentials for white blood cell types. Specifically, the CBC parameters measured by the Sight OLO are listed below and include: WBC, RBC, HGB, HCT, MCV, MCH, MCHC, RDW, PLT, NEUT%/#,\nLYMPH %/#, MONO %/#, EO%/# and BASO%/#. In addition, the Sight OLO signals specific\nWBC abnormal cases by flagging the sample.",
      "code_info": "Software versions up to and including v2.59.3.\n\nSerial Number\tUDI  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      "firm_fei_number": "3016099075",
      "recalling_firm": "SIGHT DIAGNOSTICS LTD",
      "address_1": "23, Derekh Menakhem Begin 23 Derekh Menakhem Begin",
      "city": "Tel Aviv-Yafo",
      "country": "Israel",
      "reason_for_recall": "In instances where custom reference ranges were configured on the device post installation,\na possibility to inadvertently apply changes to reference range values was found on software\nversions 2.59.3 and all earlier versions, which can potentially lead to displaying and printing\nincorrectly-configured reference range values",
      "root_cause_description": "Software design",
      "action": "Sight Diagnostics issued Medical Device Recall Notification on 1/20/22 via email to Distributors and End Users. Letter states reason for recall, health risk and action to take:\nIn case you have configured your own reference ranges, please review the configured\nvalues to ensure all values are set properly. You can then continue to use your OLO\nanalyzer.\nThe software version of the OLO analyzer in your possession will be updated to a new\nversion that resolves this software defect. The update will be performed remotely by\nSights product specialists, who will contact you to schedule the update. Please be\naware that the software version update requires the analyzer to be connected to the\ninternet.\nIf you need to make any adjustments to your reference ranges before the software\nupdate is performed, please avoid pressing the  Cancel  button while editing a\nreference range parameter, and always review all parameters after making any\nchanges, to confirm values are set properly.\nIf you are a distributor, please share this recall notification letter with any customer\nto whom the product was shipped, or may have been shipped.\nYou are kindly requested to fill the attached Acknowledgement and Receipt Form,\nand return it to notifications@sightdx.com within 30 days.\nSoftware version 2.63 was released and includes the fix for the software defect\nmentioned above.\nQuestions please contact us at Support@sightdx.com. For full indications\nfor use and safety information please refer to the Quality and Compliance page at\nwww.sightdx.com.",
      "product_quantity": "322 units: U.S 109 Foreign 213",
      "distribution_pattern": "Worldwide distribution - US Nationwide and the countries of AUSTRALIA, CANADA, CHILE, CURACAO, FINLAND, GEORGIA, GERMANY, GREECE, HONG KONG, IRELAND, ISRAEL, ITALY, \nMEXICO, NETHERLANDS, PORTUGAL, SINGAPORE, SLOVENIA, UNITED ARAB EMIRATES, \nUNITED KINGDOM.",
      "openfda": {
        "k_number": [
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