AB SCIEX 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

Check Your Product

According to the U.S. Food and Drug Administration (FDA)

Reason for Recall

As stated by FDA

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.

Recommended Action

Per FDA guidance

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.