China NMPA Product Recall - Automate 2500 Family of Fully Automated Sample Processing Systems

Beckman Coulter Trading (China) Co., Ltd. has initiated a voluntary Class III recall for its Automate 2500 Family Fully Automated Sample Processing System. This recall, published by the Shanghai Drug Administration on April 15, 2020, under the National Medical Products Administration (NMPA) regulatory framework, addresses a significant product defect. The core issue involves the system's high-speed drawer closing mechanism, which has been identified as potentially causing interference with specimens, leading to splashing. This specimen splashing creates a risk of cross-contamination, which could adversely affect the reliability of diagnostic tests and patient safety. As a required action, Beckman Coulter is proactively retrieving all affected units from the market. A Class III recall typically indicates a situation where use of or exposure to a violative product is not likely to cause adverse health consequences, but the company is taking steps to prevent potential issues. Detailed information regarding specific product models, specifications, and affected batches is available in the associated "Medical Device Recall Event Report Form" provided by the company.