Beckman Coulter Mishima K.K. is recalling 189 DxC 700 AU and AU5800 Chemistry Analyzers due to a software issue involving Microsoft SQL Server 2022 Express. If the calibration monitor is left open for more than 15 minutes, the system may experience database errors that prevent reagent blank and calibration data from opening. This defect causes the system to stop analyzing samples, which requires a service visit to resolve and may result in significant delays in patient diagnosis or treatment.
The software error causes the analyzer to stop functioning, which can delay critical lab results. Such delays may postpone necessary medical diagnoses or treatments, potentially impacting patient safety.
Includes newer instruments with PC preinstalled with Microsoft SQL Server 2022 Express and older instruments with replaced PCs.
Includes newer instruments with PC preinstalled with Microsoft SQL Server 2022 Express and older instruments with replaced PCs.
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.
AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.
Sources: FDA iRES · Raw API Response
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