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 recall of its DxI 9000 Access Immunoassay Analyzer. This action was reported to the National Medical Products Administration (NMPA) of China and published on June 27, 2024. The recall stems from a potential issue where the analyzer may experience oxidation over time, which can lead to communication interruptions between its internal subsystems. This defect could compromise the device's functionality and reliability. The affected product is identified under National Medical Device Registration Certificate No. 20242220249. While the document does not specify any inspection dates, the company is taking proactive steps to address this product deficiency. Further details regarding specific models, specifications, and batch numbers involved in this recall are outlined in a "Medical Device Recall Event Report Form." This voluntary recall underscores the company's commitment to ensuring product safety and adherence to the NMPA's regulatory standards for medical devices.