Beckman Coulter Mishima K.K. has recalled 24 DxC 500 AU Clinical Chemistry Analyzers due to two software bugs that can cause incorrect patient test results. The first issue occurs when a shared rack is used for both patient samples and calibration materials, leading the machine to misidentify a calibration result as a patient result. The second issue involves the system incorrectly allowing calibration using expired materials. These devices are used in laboratories to measure chemicals in patient samples, and errors could lead to incorrect medical diagnoses.
If the software bug causes a calibration value to be recorded as a patient test result, or if expired materials are used for calibration, a doctor could receive an inaccurate report for a patient's health. While no serious injuries or deaths have been reported, inaccurate diagnostic data can lead to improper medical treatments or delayed care.
Technical software correction and manufacturer notification
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
openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.