The Recall Desk
HighFDA (Devices)·Z-0175-2022·Announced 2021-11-03

Cliquid MD Software Version 3.4 May Provide Incorrect Analytical Results

AB SCIEX's Cliquid MD version 3.4 software may incorrectly calculate Internal Standard concentrations when users hide or leave the IS column empty in customized LC-MS/MS tests, potentially leading to incorrect analytical conclusions.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is an FDA Class II medical device software recall. Although no illnesses or injuries have been reported, the bug affects analytical test results in a medical testing system, constituting a risk-of-harm product per the severity rubric. The incorrect data calculations could lead to wrong medical conclusions.

Plain-English summary

AB SCIEX has recalled Cliquid MD version 3.4 software used with Analyst MD software on SCIEX Citrine and 4500MD series liquid chromatography-tandem mass spectrometry (LC-MS/MS) systems. The software incorrectly calculates Internal Standard (IS) concentrations when a user builds a customized test, sets the IS column to hidden, and leaves the column empty. This calculation error may result in incorrect analytical values and conclusions.

The affected software has been distributed worldwide, including to users in the United States (District of Columbia, Florida, Illinois, Louisiana, Maryland, Michigan, Missouri, New Jersey, New York, North Carolina, Ohio, Pennsylvania, Tennessee, Utah, and Wisconsin) and internationally (Austria, Finland, Germany, Hong Kong, Italy, Japan, Norway, Spain, Switzerland, United Kingdom, and France). Approximately 30 systems are affected.

Users of Cliquid MD version 3.4 should be aware of this issue and review their customized tests, particularly those where the Internal Standard column was hidden or left empty, as these tests may contain incorrect analytical results.

The recalled product

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
AB SCIEX
Category
Medical Device — Laboratory Analysis Equipment
Hazard
  • incorrect-results
  • calculation-error

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • Software version 3.4

Distribution

Distributed nationwide across the United States.

Related recalls

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