FDA Medical Device Recalls (openFDA)
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 number
- Z-0175-2022
- Recalling firm
- AB SCIEX
- 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
- Status
- Terminated
- Initiated
- 2021-10-04
- Posted
- not on file
- Terminated
- 2024-01-23
- 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.
- 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
- 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.
- Lot, serial or model codes
- Software version 3.4
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- DOP
- Firm FEI
- 3008336863
- Firm city
- Concord
- Firm state
- not on file
- Firm country
- Canada
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28