China NMPA Product Recall - DxI 9000 Access Immunoassay Analyzer - Fully Automated Chemiluminescence Immunoassay Analyzer

Beckman Coulter, Inc., through its subsidiary Beckman Coulter Trading (China) Co., Ltd., has initiated a voluntary Class II recall of its DxI 9000 Access Immunoassay Analyzer. This action, reported to the National Medical Products Administration (NMPA) on February 25, 2025, addresses a critical issue with the device. The primary concern stems from a malfunction where the Z-axis tray clamping motor experiences forced stops. This defect leads to significant operational problems, specifically causing malfunction alarms and, more critically, delays in reporting patient test results. Such delays can have serious implications for timely medical diagnosis and treatment. The recall impacts specific product models, specifications, and batch numbers, which are detailed in an accompanying Medical Device Recall Event Report Form. As part of this voluntary action, the company is responsible for retrieving affected analyzers from the market. This recall underscores the importance of device reliability in medical diagnostics and the NMPA's role in overseeing product safety and compliance within China's medical device industry.