China NMPA Product Recall - Fully Automated Immunoassay System

The National Medical Products Administration (NMPA) issued a notice regarding a voluntary Class II recall initiated by Beckman Coulter, Inc. (USA). This recall, reported by Beckman Coulter Trading (China) Co., Ltd., concerns their Automated Immunoassay System, registered under National Medical Device Registration Certificate No. 20162224740. The primary issue identified involves potential reagent stage movement errors that may occur during the unloading or loading of reagent packs within the system. It is important to note that the affected product was not imported into China. Therefore, the recall actions primarily impact markets outside of China where specific Immunoassay System models, specifications, and batch numbers, detailed in the accompanying "Medical Device Recall Event Report Form," were distributed. The regulatory framework for this action falls under the NMPA's oversight for medical device safety. This proactive measure by Beckman Coulter, Inc. underscores their commitment to addressing potential device malfunctions to ensure patient safety and product reliability.