China NMPA Product Recall - DxI9000 Access Immunoassay Analyzer (Fully Automated Chemiluminescence Immunoassay Analyzer)

The National Medical Products Administration (NMPA) announced a voluntary recall initiated by Beckman Coulter, Inc. on March 27, 2025, concerning its DxI9000 Access Immunoassay Analyzer. This action was prompted by critical performance issues, specifically the washing disc mixer failing to rotate freely and subsystem communication failures. These technical deficiencies pose a significant risk of delaying patient diagnosis or treatment. Beckman Coulter Trading (China) Co., Ltd. reported these issues on behalf of the manufacturer, Beckman Coulter, Inc., leading to a formal "Recall Level: Recall" designation. It is important to note that the specific products affected by this recall were not imported into the Chinese market. Detailed information, including affected models and batches, is provided in the accompanying Medical Device Recall Event Report Form. This recall highlights the NMPA's regulatory oversight and commitment to medical device safety, even for products not directly distributed within China but manufactured by companies subject to its purview.