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

The National Medical Products Administration (NMPA) announced on June 14, 2024, a Class II voluntary recall initiated by Beckman Coulter, Inc., concerning its DxI 9000 Access Immunoassay Analyzer. The recall was formally reported by Beckman Coulter Trading (China) Co., Ltd. The main issue identified is the potential for test samples to become unmanageable following the product's repackaging. This critical concern affects specific models, specifications, and batches of the analyzer, which is registered under National Medical Device Registration Certificate No. 20242220249. Under the NMPA's regulatory framework, a Class II recall indicates that the product could cause temporary or reversible adverse health consequences, or that the likelihood of serious adverse health consequences is remote. Beckman Coulter, Inc. is undertaking this action to address a potential product quality and safety risk, ensuring compliance with medical device regulations. The required action involves detailing all affected units in a "Medical Device Recall Event Report Form" to facilitate their removal from the market and prevent potential issues in diagnostic testing stemming from the identified packaging concern. This proactive measure underscores the commitment to patient safety and product integrity.