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Lower risk Medical device recall · FDA · Published October 4, 2021

AB SCIEX Cliquid MD v3.4 Software Recall: Incorrect Internal Standard Results

AB SCIEX recalls Cliquid MD version 3.4 software for incorrect internal standard calculations, risking inaccurate test results in LC-MS/MS systems.

🇺🇸 FDA recall #Z-0175-2022Medical deviceAB SCIEX ›
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Recalling firmAB SCIEX71 Four Valley Dr · Concord, Canada
✎ GovInfoNow plain-language explainer

AB SCIEX is recalling Cliquid MD version 3.4 software used with Analyst MD software on certain LC-MS/MS systems. This software error can cause incorrect internal standard calculations, leading to unreliable test results if users build customized tests and hide the internal standard column. Read more at govinfonow.com/recall/61719-ab-sciex-cliquid-md-v3-4-software-recall-incorrect-internal.

Source Summary by GovInfoNow · govinfonow.com/recall/61719-ab-sciex-cliquid-md-v3-4-software-recall-incorrect-internal · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0175-2022

Cite this page

“AB SCIEX Cliquid MD v3.4 Software Recall: Incorrect Internal Standard Results.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/61719-ab-sciex-cliquid-md-v3-4-software-recall-incorrect-internal. Based on FDA recall #Z-0175-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0175-2022%22&limit=1).

The FDA announced on Oct. 4, 2021, that AB SCIEX is recalling Cliquid MD version 3.4 software due to a hazard involving incorrect internal standard concentration values. The agency stated the recall was voluntarily initiated by the firm.

How to tell if you have it

  • Brand: AB SCIEX
  • Product: Cliquid MD version 3.4 software used with Analyst MD software on SCIEX Citrine & 4500MD series liquid chromatography-tandem mass spectrometry (LC-MS/MS) systems
  • Model No.: 5088288
  • Software version: 3.4

The hazard

According to the FDA, the values of the Internal Standard (IS) concentrations are incorrectly derived when a user builds a customized test, sets the IS column to hidden, and leaves the column empty. This error may lead users to make incorrect conclusions based on incorrect results.

Context

GovInfoNow's records show other recent recalls of similar products include Roche cobas pro integrated solutions (2026-01-20), Siemens Dimension Creatinine Flex Reagent Cartridge (2026-03-18), and DxC 500i Clinical Analyzer Modules (2026-09-02).

How to tell if you have this one

Check if you have Cliquid MD version 3.4 software installed with Analyst MD software on SCIEX Citrine or 4500MD series LC-MS/MS systems. Model number 5088288 is associated with this software version.

  • Brand
    AB SCIEX
  • Category
    Medical device
Based on the official FDA remedy

What to do — step by step

  1. Update Software

    Install the latest Cliquid MD software version to correct the internal standard calculation error.

Where it went and when

Where it was distributed

Distributed nationwide and abroad; the notice names 14 states.

Alaska: nationwideAKMaine: nationwideMEVermont: nationwideVTNew Hampshire: nationwideNHWashington: nationwideWAIdaho: nationwideIDMontana: nationwideMTNorth Dakota: nationwideNDMinnesota: nationwideMNIllinois: named in the noticeILWisconsin: named in the noticeWIMichigan: named in the noticeMINew York: named in the noticeNYRhode Island: nationwideRIMassachusetts: nationwideMAOregon: nationwideORNevada: nationwideNVWyoming: nationwideWYSouth Dakota: nationwideSDIowa: nationwideIAIndiana: nationwideINOhio: named in the noticeOHPennsylvania: named in the noticePANew Jersey: named in the noticeNJConnecticut: nationwideCTCalifornia: nationwideCAUtah: named in the noticeUTColorado: nationwideCONebraska: nationwideNEMissouri: named in the noticeMOKentucky: nationwideKYWest Virginia: nationwideWVVirginia: nationwideVAMaryland: named in the noticeMDDelaware: nationwideDEArizona: nationwideAZNew Mexico: nationwideNMKansas: nationwideKSArkansas: nationwideARTennessee: named in the noticeTNNorth Carolina: named in the noticeNCSouth Carolina: nationwideSCDistrict of Columbia: named in the noticeDCOklahoma: nationwideOKLouisiana: named in the noticeLAMississippi: nationwideMSAlabama: nationwideALGeorgia: nationwideGAHawaii: nationwideHITexas: nationwideTXFlorida: named in the noticeFL

FDA 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…” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: District of Columbia, Florida, Illinois, Louisiana, Maryland, Michigan, Missouri, New Jersey, New York, North Carolina, Ohio, Pennsylvania, Tennessee, Utah, Wisconsin.

Recall timeline

FDA terminated this recall 2.3 years after the firm started it.

1. Firm started the recall: Oct 4, 202112. FDA classified it Class II: Oct 26, 202123. Published in FDA’s Enforcement Report: Nov 3, 202134. FDA terminated the recall: Jan 23, 2024420212024
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report
  4. FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

✎ GovInfoNow

Questions people ask

Do I need to stop using the software immediately?

No, the recall does not require immediate discontinuation; updating to the latest software version resolves the issue.

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Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

  • Official source: FDA Recall #Z-0175-2022 (October 4, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0175-2022 to see it in context.
  • Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
  • GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA