Beckman Coulter Mishima K.K. Recalls

3 recalls on record in the United States

medical: 3
medical Class II
2026-03-18

Beckman Coulter Mishima K.K. recalls CHEMISTRY ANALYZER AU5800, REF: B96697, B96698, B23279, B232

A delay in results may occur. When clinical chemistry analyzer calibration monitor with PC installed with Microsoft SQL Server 2022 Express is open beyond15 minutes may lead to: Reagent Blank and calibration databases not opening errors: CAL History DB Open Error.., RB History DB Open Error..; system will stop analyzing, firm service must visit to apply software solution; may lead to delay in diagnosis and/or patient treatment

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medical Class II
2026-03-18

Beckman Coulter Mishima K.K. recalls DxC 700 AU, REF: B86444, B86446

A delay in results may occur. When clinical chemistry analyzer calibration monitor with PC installed with Microsoft SQL Server 2022 Express is open beyond15 minutes may lead to: Reagent Blank and calibration databases not opening errors: CAL History DB Open Error.., RB History DB Open Error..; system will stop analyzing, firm service must visit to apply software solution; may lead to delay in diagnosis and/or patient treatment.

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medical Class II
2026-10-07

Beckman Coulter Mishima K.K. recalls Systems/units containing affected software/SQL BECKMAN COUL

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.

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