China NMPA Product Recall - Fully automated sample processing system (Automate 1250, Automation 2550)

Beckman Coulter, Inc. initiated a Class III voluntary recall, reported to China's National Medical Products Administration (NMPA) on December 4, 2018, regarding its Fully Automated Sample Processing Systems (Automate 1250 and Automate 2550). The recall stems from a potential for cross-contamination of samples. This issue can occur when the system's MTP module is operated without the necessary "Sorting Drive" software (V4.1.2 or above) and if the Laboratory Information System (LIS) is not configured to support all communication requirements. This problem does not arise if the MTP module is unused or operated in manual mode. While the recall impacts units in regions like France, Italy, and the UK, no affected products were sold or distributed in China. Consequently, the Chinese agent, Beckman Coulter Trading (China) Co., Ltd., reported the global recall to the NMPA. No specific corrective actions were required for the Chinese market as no units were affected locally. The regulatory framework is the NMPA's medical device recall process.