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U.S. Department of Health and Human Services

Class 2 Device Recall Cliquid MD

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  Class 2 Device Recall Cliquid MD see related information
Date Initiated by Firm October 04, 2021
Create Date October 26, 2021
Recall Status1 Terminated 3 on January 23, 2024
Recall Number Z-0175-2022
Recall Event ID 88748
Product Classification Mass spectrometer, clinical use - Product Code DOP
Product 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 Information Software version 3.4
Recalling Firm/
Manufacturer		 AB SCIEX
71 Four Valley Dr
Concord Canada
Manufacturer 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.
FDA Determined
Cause 2		 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: 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.
Quantity in Commerce 30
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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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