Z-0175-2022Class II

Cliquid MD version 3.4 software used in conjunction with Analyst MD software on SCIEX Citrine & 4500MD series...

Name: Z-0175-2022 Cliquid MD version 3.4 software used in conjunction with Analyst MD software on SCIEX Citrine & 4500MD series...
Creator: Ab Sciex
Published: 2021-10-04
License: https://open.fda.gov/license/

AB Sciex, LLC / initiated 2021-10-04 / Terminated / root cause: software

FDA source

AB SCIEX began a recall of Cliquid MD version 3.4 software used in conjunction with Analyst MD software on SCIEX Citrine & 4500MD series liquid chromatography-tandem mass spectrometry... on 2021-10-04. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-0175-2022
Classification: Class II
Status: Terminated
Initiated: 2021-10-04
Posted: 2021-10-26
Terminated: 2024-01-23
Recalling firm: AB Sciex, LLC
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
Product code: DOP Mass Spectrometer, Clinical Use
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 tag: software
FDA root cause: 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.
Product codes and lots: Software version 3.4

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0175-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0175-2022	Class II	Terminated	Voluntary: Firm initiated	2021-11-03	2021-10-26

Product code DOP

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)