Nov

2021

Recall – Incorrect results from mass spectrometry system

Company: AB SCIEX
Date of Enforcement Report: 11/3/2021
Class II

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

Recall Number: Z-0175-2022

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.

RECALLING FIRM/MANUFACTURER

AB SCIEX on 10/4/2021. Voluntary: Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE

DISTRIBUTION

U.S. Nationwide and International

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Recall – Incorrect results from mass spectrometry system

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