Lower risk Medical device recall · FDA · Published May 30, 2023

Abbott Alinity ci-series System Control Module Software Issues: Erroneous Test Results

Abbott recalls Alinity ci-series System Control Module software versions 3.4.0 and lower due to potential erroneous test results. Affected users should check their software version and contact Abbott for updates.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-0613-2024Medical device Abbott ›

Lower-risk recall

There are potential performance issues found in the Alinity ci-series System software versions 3.4.0 and lower, including: 1) SCC Reagent load error during daily maintenance; 2) Sample Laboratory Report error; 3) Customer requests mechanism to prevent user error when creating new lots of value assigned Calibrators; 4) Error in processing tests after CCCintController encountered an error with the assay information downloaded from SCC; 5) The assay editor does not correctly check sample dilution total volume limits; 6) User-Applied Labels not adhering to Reagent Bottles; 7) ICT Module did not expire after warranty was exceeded. These performance issues could lead to erroneous results for multiple analytes.

Take action

Contact the company

Recalling firmAbbott Laboratories1915 Hurd Dr · Irving, TX 75038-4313

✎ GovInfoNow plain-language explainer

Abbott is recalling Alinity ci-series System Control Module software versions 3.4.0 and lower because these versions can cause incorrect test results. This affects labs using the system and could lead to inaccurate medical testing. Read more at govinfonow.com/recall/57930-abbott-alinity-ci-series-system-control-module-software-issues-erroneous.

Source Summary by GovInfoNow · govinfonow.com/recall/57930-abbott-alinity-ci-series-system-control-module-software-issues-erroneous · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0613-2024

Cite this page

“Abbott Alinity ci-series System Control Module Software Issues: Erroneous Test Results.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/57930-abbott-alinity-ci-series-system-control-module-software-issues-erroneous. Based on FDA recall #Z-0613-2024 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0613-2024%22&limit=1).

The FDA announced on May 30, 2023, that Abbott Laboratories is recalling Alinity ci-series System Control Modules due to potential software performance issues. These defects could lead to erroneous results for multiple analytes.

How to tell if you have it

Brand: Abbott
Product: Alinity ci-series System Control Module
REF: 03R70-01
UDI-DI: 00380740137410
Software Version: 3.4.0 and lower

The hazard

According to the FDA, potential performance issues in software versions 3.4.0 and lower include reagent load errors, sample report errors, and incorrect sample dilution volume checks. These issues could lead to erroneous results for multiple analytes.

Context

GovInfoNow's records show Abbott Laboratories has had 33 other recalls since May 14, 2012. Other recent recalls of similar products include Beckman Coulter DxC 500i Modules with Software 1.5 Risk: Erroneous Test Results (July 15, 2026), Roche cobas pro integrated solutions recall: Software defect causes incorrect lab results (Jan. 20, 2026), and Abbott Medical Merlin PCS 365: Software malfunction risks pacemaker test failure (May 12, 2026).

How to tell if you have this one

Check if your Alinity ci-series System Control Module has software version 3.4.0 or lower. The product is identified by the reference number 03R70-01 and UDI-DI: 00380740137410.

Brand
Abbott
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Software Version
Verify your Alinity ci-series System Control Module software version; affected units have version 3.4.0 or lower.

Where it went and when

Where it was distributed

Distributed in 45 states and Puerto Rico, and outside the U.S.

FDA distribution: “US: AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV OUS: ALBANIA, ALGERIA, ARGENTINA, AUSTRALIA,…” States read from FDA’s own wording; “not listed” means the notice does not name it.

States: Alabama, Alaska, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, Florida, Georgia, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nevada, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, West Virginia, Wisconsin.

Recall timeline

FDA published this recall 7 months after the firm started it.

May 30, 2023Firm started the recall
Dec 22, 2023FDA classified it Class II
Jan 3, 2024Published in FDA’s Enforcement Report

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

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Keep exploring

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Link to this recall

<a href="https://govinfonow.com/recall/57930-abbott-alinity-ci-series-system-control-module-software-issues-erroneous">Abbott Alinity ci-series System Control Module Software Issues: Erroneous Test Results (GovInfoNow)</a>

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-0613-2024 (May 30, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0613-2024 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.