Lower risk Medical device recall · FDA · Published August 3, 2026

AU480 Chemistry Analyzer May Show Error Message Causing Delay in Patient Results

Beckman Coulter recalls 492 AU480 Chemistry Analyzers with specific UDI-DI codes that may show a system error message, delaying patient results. Affected units include those with Windows 10 IoT Enterprise 2021 LTSC PCs and Microsoft SQL Server 2022 Express software.

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

🇺🇸 FDA recall #Z-3332-2026Medical device Beckman Coulter ›

Lower-risk recall

Certain AU480 chemistry analyzers, with Windows 10 IoT Enterprise 2021 LTSC PCs, may output the message System Stopped By Fatal Error: DBConnectionError AlarmDB when launching the instrument software, using PC pre-installed with Microsoft SQL Server 2022 Express. When this occurs, AlarmDB becomes unreadable and the instrument software cannot be started. This causes a delay in obtaining patient results.

✎ GovInfoNow plain-language explainer

Beckman Coulter is recalling 492 AU480 Chemistry Analyzers that may display a system error message when launching the instrument software. This error prevents the analyzer from starting, causing delays in obtaining patient test results. Read more at govinfonow.com/recall/1449445-beckman-coulter-mishima-k-k-recalls-systems-units-containing-affected.

Source Summary by GovInfoNow · govinfonow.com/recall/1449445-beckman-coulter-mishima-k-k-recalls-systems-units-containing-affected · Updated October 14, 2026 · FDA enforcement record: FDA #Z-3332-2026

Cite this page

“AU480 Chemistry Analyzer May Show Error Message Causing Delay in Patient Results.” GovInfoNow, updated October 14, 2026. https://govinfonow.com/recall/1449445-beckman-coulter-mishima-k-k-recalls-systems-units-containing-affected. Based on FDA recall #Z-3332-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3332-2026%22&limit=1).

The FDA announced on August 3, 2026, that Beckman Coulter Mishima K.K. is recalling 492 AU480 Chemistry Analyzers worldwide due to software issues that may delay patient test results. The agency issued recall number Z-3332-2026 for the voluntary Class II action.

How to tell if you have it

Brand: Beckman Coulter
Product: AU480 Chemistry Analyzer
Item Number B96692 / UDI-DI code 14987666542965
Item Number B96693 / UDI-DI code 14987666542972
Item Number B12183 / UDI-DI code 14987666540671

The hazard

According to the FDA, certain AU480 chemistry analyzers with Windows 10 IoT Enterprise 2021 LTSC PCs may output a fatal error message when launching instrument software. This issue renders AlarmDB unreadable and prevents the instrument software from starting, causing a delay in obtaining patient results.

Context

GovInfoNow's records show Beckman Coulter Mishima K.K. has had four other recalls on record since June 5, 2024. Other recent recalls of similar products include Beckman Coulter DxC 700 AU Recall (January 30, 2026) and Beckman Coulter Sample Probes May Cause False Low Test Results (April 30, 2025). Additional related actions include the Beckman Coulter UniCel Dxl 600 recall (November 26, 2025), the Beckman Coulter UniCel Dxl 800 recall (November 26, 2025), and the Beckman Coulter DxC 500 AU Modules recall (July 15, 2026).

How to tell if you have this one

Check for UDI-DI codes: 14987666542965, 14987666542972, or 14987666540671 on the device. The affected units include those with Windows 10 IoT Enterprise 2021 LTSC PCs and Microsoft SQL Server 2022 Express software.

Brand
Beckman Coulter
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check for Error Message
Look for the message 'System Stopped By Fatal Error: DBConnectionError AlarmDB' when launching the instrument software.

Where it went and when

Where it was distributed

Distributed nationwide and abroad; the notice names 21 states.

FDA distribution: “Worldwide - U.S. Nationwide distribution in the states of AR, CA, DE, FL, GA, GU, HI, IA, IL, IN, KS, KY, MN, MO, NC, NM, NY, OK, PA, SD, TX, and WI. The countries of Algeria, Australia, Belarus, Bosnia and Herzegovina, Brazil, Bulgaria,…” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: Arkansas, California, Delaware, Florida, Georgia, Hawaii, Illinois, Indiana, Iowa, Kansas, Kentucky, Minnesota, Missouri, New Mexico, New York, North Carolina, Oklahoma, Pennsylvania, South Dakota, Texas, Wisconsin.

Recall timeline

FDA published this recall 2 months after the firm started it.

Aug 3, 2026Firm started the recall
Sep 30, 2026FDA classified it Class II
Oct 7, 2026Published in FDA’s Enforcement Report
Oct 13, 2026Added to GovInfoNow

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

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Link to this recall

<a href="https://govinfonow.com/recall/1449445-beckman-coulter-mishima-k-k-recalls-systems-units-containing-affected">AU480 Chemistry Analyzer May Show Error Message Causing Delay in Patient 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-3332-2026 (August 3, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-3332-2026 to see it in context.
Plain-language summary written by qwen3:4b on October 14, 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.