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
30
DISTRIBUTION
U.S. Nationwide and International