FDA recall Z-0175-2022

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

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.

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.

Key facts

Status

Terminated

Initiation date

2021-10-04

Report date

2021-11-03

Termination date

2024-01-23

Voluntary/Mandated

Voluntary: Firm initiated

Location

Concord, N/A, Canada

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0175-2022