BEUDAMED
    FDA Enforcement Class II 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 · Reported November 3, 2021

    Enforcement

    Recall Number
    Z-0175-2022
    Event ID
    88748
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    AB SCIEX
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    November 3, 2021
    Initiation Date
    October 4, 2021
    Classification Date
    October 26, 2021
    Termination Date
    January 23, 2024
    Address
    71 Four Valley Dr, N/A, Concord, N/A, N/A, 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.

    Code Info

    Software version 3.4

    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