China NMPA Product Recall - Power Processor Automated Sample Processing System

Beckman Coulter Trading (China) Co., Ltd. initiated a voluntary Class III recall of its Power Processor Automated Sample Processing System, as reported by the National Medical Products Administration (NMPA) on August 31, 2021. The recall stems from the company's discovery that essential track-grade splash guards, crucial for the safe operation of the system, were not consistently supplied to all customers. This oversight necessitated corrective action to ensure product safety and compliance. The company is taking proactive measures to address this issue by recalling affected units, details of which are outlined in the accompanying "Medical Device Recall Event Report Form." This action underscores the company's commitment to product safety under the regulatory oversight of the NMPA and the Shanghai Municipal Drug Administration.