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 (Registration Certificate No.: 20150277) on June 19, 2019. This action, reported to the National Medical Products Administration (NMPA) of China, addresses a critical product deficiency. The primary issue identified is the potential for sample spillage during the transfer of specimens from the specimen rack to the specimen carrier. This spillage is attributed to possible vibration and speed irregularities of the system's unloading robotic arm, which could compromise the integrity of sample processing. Under the oversight of the NMPA, this voluntary recall demonstrates the company's commitment to product safety and quality. A Class III recall indicates that the product defect is unlikely to cause adverse health consequences. Specific details regarding the affected models, specifications, and batch numbers are documented in the accompanying "Medical Device Recall Event Report Form," which stakeholders are directed to consult for comprehensive information. This proactive measure ensures compliance with regulatory standards and mitigates potential risks associated with the use of the device in clinical settings.