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Open, Classified

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.

FDA Recall Z-3332-2026 · Posted 2026-10-01

Recalling FirmBeckman Coulter Mishima K.K.
Recall StatusOpen, Classified
Product CodeJJE
Date Initiated2026-08-03
Product Quantity492 units

Reason for 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.

Firm Action

On 08/03/2026, an "URGENT MEDICAL DEVICE RECALL" Letter was sent via postal mail and email informing customers that CHEMISTRY ANALYZER AU480 with Windows 10 IoT Enterprise 2021 LTSC PCsmay 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. Customers are instructed to: 1. Be sure to create a new index once or more per day at an appropriate time. Refer to 5.1 Start the System of the IFU to complete this action. 2. Beckman Coulter recommends posting this letter on or near the affected analyzers. Resolution - Beckman Coulter has identified the root cause and will resolve the issue by applying a Software solution to the impacted systems. BEC service teamwill contact customers to schedule the Software solution application, and a Field Service Engineer (FSE) will perform the on-site work. For questions - contact Customer Support Center at: http://www.beckmancoulter.com

Root Cause

Software design

Distribution Pattern

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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K981743OLYMPUS AU400 CLINICAL CHEMISTRY ANALYZEROlympus America, Inc. · 1998-06-09

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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