{
  "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": "2026-08-20",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "189437",
      "product_res_number": "Z-0175-2022",
      "event_date_initiated": "2021-10-04",
      "event_date_created": "2021-10-26",
      "recall_status": "Terminated",
      "event_date_terminated": "2024-01-23",
      "res_event_number": "88748",
      "product_code": "DOP",
      "product_description": "Cliquid MD version 3.4 software used in conjunction with Analyst MD software on SCIEX Citrine & 4500MD series liquid chromatography-tandem mass spectrometry (LC-MS/MS) systems. Model No. 5088288",
      "code_info": "Software version 3.4",
      "firm_fei_number": "3008336863",
      "recalling_firm": "AB SCIEX",
      "address_1": "71 Four Valley Dr",
      "city": "Concord",
      "country": "Canada",
      "reason_for_recall": "The values of the Internal Standard (IS) concentrations are incorrectly derived when the user builds a customized test, then set the IS column to hidden and left the column empty. This may lead to the user making incorrect conclusions using incorrect results.",
      "root_cause_description": "Software Design Change",
      "action": "On October 4, 2021, the firm distributed Urgent Medical Device Correction letters to affected consignees. Customers were provided with temporary actions that could be implemented for safe handling of the recalled software to prevent the reporting of incorrect results to healthcare providers resulting in incorrect conclusions:\n\n1. Avoid setting the IS (Internal Standard) column as hidden AND leaving it empty\n2. Review values in the IS Concentration column\n3. Follow lab SOPs to ensure quality control\n\nSCIEX is working on the hotfix for Cliquid MD Software version 3.4 and will contact affected customers as soon as it is ready\nThe hotfixes may be downloaded free of charge directly from SCIEX s website, at the following location:\nhttps://sciex.com/software-support/software-downloads\nSoftware release notes will provide detailed installation instructions for installing the Hotfix.\n\nIf you have any questions, please contact customer service at 1-877-740-2129, option 1, and then option 4, or your local SCIEX support number. You may also submit questions through their web portal at https://sciex.com/request-support.",
      "product_quantity": "30",
      "distribution_pattern": "Worldwide distribution - US Nationwide distribution in the states of District of Columbia,\nFlorida, Illinois, Louisiana, Maryland, Michigan, Missouri, New Jersey, New York, North Carolina, Ohio, Pennsylvania, Tennessee, Utah, Wisconsin and the countries of Austria, Finland, Germany, Hong Kong, Italy, Japan, Norway, Spain, Switzerland, United Kingdom, Italy, France, and Japan.",
      "openfda": {
        "k_number": [
          "K992163",
          "K872464",
          "K770637",
          "K880089",
          "K974322",
          "K810938",
          "K880418",
          "K770994",
          "K854076",
          "K880090"
        ],
        "registration_number": [
          "3000221947",
          "3010962166",
          "3009189893",
          "3043138885",
          "2916205",
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          "1218959",
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          "3007386004",
          "3003423869"
        ],
        "fei_number": [
          "3000221947",
          "3010962166",
          "3009189893",
          "3043138885",
          "2916205",
          "3043088937",
          "1218959",
          "3002806559",
          "3001040364",
          "3002808498",
          "3008336863",
          "3009715051",
          "3003179344",
          "3010607747",
          "3003809634",
          "3003559576",
          "3007386004",
          "3003423869"
        ],
        "device_name": "Mass Spectrometer, Clinical Use",
        "medical_specialty_description": "Clinical Chemistry",
        "regulation_number": "862.2860",
        "device_class": "1"
      }
    }
  ]
}