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

The National Medical Products Administration (NMPA) in China announced a Class II voluntary recall initiated by Beckman Coulter, Inc., and reported by its Chinese subsidiary, Beckman Coulter Trading (China) Co., Ltd. Published on September 29, 2025, this action addresses a significant concern with the DxI9000 Access Immunoassay Analyzer (National Medical Device Registration Certificate No. 20242220249). The core issue identified is the potential for incorrect dilution factor usage during analysis. This defect can lead to unreliable test results, specifically yielding either falsely high or falsely low measurements. Such inaccuracies present a serious risk, potentially compromising patient diagnosis and subsequent medical treatment. Beckman Coulter, Inc. is proactively recalling these devices to mitigate the safety and efficacy concerns. The recall is focused on units distributed and currently located within China. Comprehensive details regarding the affected product batches are provided in the "Medical Device Recall Event Report Form," highlighting the NMPA's commitment to ensuring the safety and quality standards of medical devices in its market.