China NMPA Product Recall - Automated Sample Processing System

Beckman Coulter Trading (China) Co., Ltd. initiated a voluntary Class III recall of its Automated Sample Processing System, known as the Power Processor, as reported on December 7, 2021, by the National Medical Products Administration (NMPA) and the Shanghai Municipal Drug Administration. The company's internal investigation revealed a critical safety concern: the track-grade splash guard, a protective device vital for the system's safe operation, was not consistently supplied to all customers. This omission poses a potential risk during the use of the automated sample processing system. The recall specifically targets affected models, specifications, and batches of the device, details of which are provided in an accompanying "Medical Device Recall Event Report Form." This action is an update to an earlier recall, identified as 沪药监械主召2021-186(更1), indicating an amendment to include six additional devices. The regulatory framework overseeing this recall is managed by the NMPA, with enforcement and reporting through the Shanghai Municipal Drug Administration. Beckman Coulter is responsible for ensuring the recall requirements and handling methods are met to address this product deficiency and safeguard user safety.