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AB SCIEX recalls Cliquid MD version 3.4 software used in conjunction with Analyst MD software on SCIEX Citrine & 4500MD series liquid chr
Recalled November 3, 2021 · FDA recall Z-0175-2022 · AB SCIEX
Hazard
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 Class II
Units
30
Sold at
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.
Description
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.
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
Manufacturer(s)
AB SCIEX
Made in
Canada
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →