BEUDAMED
    FDA Recall Terminated

    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

    Recall: Z-0175-2022 · Initiated October 4, 2021

    Recall

    Recall Number
    Z-0175-2022
    Event Number
    88748
    Firm
    AB SCIEX
    FEI Number
    3008336863
    Product Code
    DOP
    Status
    Terminated
    Root Cause
    Software Design Change
    Initiated
    October 4, 2021
    Terminated
    January 23, 2024
    Address
    71 Four Valley Dr, Concord Canada

    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

    Reason

    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.

    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: 1. Avoid setting the IS (Internal Standard) column as hidden AND leaving it empty 2. Review values in the IS Concentration column 3. Follow lab SOPs to ensure quality control SCIEX is working on the hotfix for Cliquid MD Software version 3.4 and will contact affected customers as soon as it is ready The hotfixes may be downloaded free of charge directly from SCIEX s website, at the following location: https://sciex.com/software-support/software-downloads Software release notes will provide detailed installation instructions for installing the Hotfix. If 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.

    Distribution

    Worldwide distribution - US Nationwide distribution in the states of District of Columbia, Florida, 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.

    Quantity

    30