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

Beckman Coulter, Inc., in collaboration with its Chinese subsidiary, Beckman Coulter Trading (China) Co., Ltd., has initiated a voluntary recall for its DxI 9000 Access Immunoassay Analyzer. This action, publicly reported on August 23, 2024, under the oversight of the National Medical Products Administration (NMPA), addresses a significant product design flaw. The core issue involves the insufficient size of pneumatic tubing within the reagent storage module, which creates a risk of damaging the module's circuit board during the analyzer's startup sequence. Such damage could potentially compromise the device's operational integrity and diagnostic accuracy. While the recall targets specific models and batches of the DxI 9000 Access Immunoassay Analyzer, Beckman Coulter has confirmed that none of the affected products were imported into the Chinese market. Detailed information regarding the involved products, including specifications and batch numbers, is provided in the "Medical Device Recall Event Report Form" submitted by the company. This proactive voluntary recall reflects the manufacturer's commitment to ensuring product safety and maintaining adherence to regulatory standards.