FDA-Device2026-10-07Class IIPROCESSING DEFECT

Beckman Coulter AU480 Chemistry Analyzer recalled for software error causing delayed patient results

OTHERNationwide distributionMedical devices

What this means

Certain Beckman Coulter AU480 Chemistry Analyzers may fail to start due to a software error when the system boots. When this happens, the instrument cannot begin processing patient samples, which delays test results. This affects approximately 492 units distributed worldwide.

If you operate an AU480 analyzer, check if your unit is affected by reviewing the item numbers B96692, B96693, B12183, or N3151400.
Contact Beckman Coulter immediately if your analyzer shows the 'DBConnectionError AlarmDB' error message.
Do not attempt to restart the software repeatedly; contact the manufacturer for technical support.
Follow guidance from Beckman Coulter regarding a software patch or corrective action.

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The agency's original wording

Hazard

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.

Intended for

Adults

Illnesses reported

None reported

Sold states

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, Canada, China, Costa Rica, Croatia, Cyprus, Czechia, Egypt, France, Germany, Guatemala, Hungary, India, Ireland, Italy, Japan, Kazakhstan, Korea, Republic of, Latvia, Malaysia, Morocco, Myanmar, Nepal, Nigeria, Pakistan, Poland, Romania, Russian Federation, Saudi Arabia, Senegal, Serbia, South Africa, Taiwan, Province of China, Turkey, United Arab Emirates, and Viet Nam.

Affected count

492 units

Manufactured in

454-32, Higashino; Nagaizumi-Cho, Sunto-Gun, Japan

Products

Systems/units containing affected software/SQL BECKMAN COULTER CHEMISTRY ANALYZER AU480 REF / UDI-DI code: B96692 / 14987666542965 B96693 / 14987666542972 B12183 / 14987666540671 The AU480 Chemistry Analyzer measure analytes in samples, in combination with appropriate reagents, calibrators, quality control (QC) material, and other accessories. This system is for in vitro diagnostic use only.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3332-2026

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