Beckman Coulter Mishima K.K.: Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
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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.
- Tags
- FDA recall, medical device, class 1, Clinical Chemistry, Software design, Open, Classified
- Related exam domains
- CISSP 3: Security Architecture and Engineering; CISSP 8: Software Development Security; CISA 3: Information Systems Acquisition, Development and Implementation; CISA 5: Protection of Information Assets
- Source record id
- Z-3332-2026
- First seen by InfoSec Signals
- 10/9/2026
Source: openFDA device recalls, U.S. Food and Drug Administration about this source more from it
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