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

This document from the National Medical Products Administration (NMPA), published on December 20, 2018, details a voluntary Class III recall initiated by Beckman Coulter, Inc. The recall, formally reported on December 4, 2018, concerns their Fully Automated Sample Processing System, specifically models Automate 1250 and Automate 2550 (Medical Device Registration No. 20151954). The primary issue identified is the potential for cross-contamination of samples. This risk materializes when the system's MTP module is used without the required "Sorting Drive" software (version 4.1.2 or above), and if the Laboratory Information System (LIS) lacks proper configuration for all communication requirements. This problem does not affect the sorting module or manual MTP module usage. While the recall affects products identified by specific batch numbers (e.g., ODL05053, C04983) in international markets such as France, Italy, and the UK, Beckman Coulter Trading (China) Co., Ltd. confirmed that no affected units of these specific models were sold within China. Therefore, the required action in China is noted as "not applicable" due to the absence of distributed affected products. The recall underscores the importance of stringent software and system integration for medical device functionality and patient safety.