China NMPA Product Recall - Cortisol Assay Kit (Chemiluminescence Method)

Beckman Coulter, Inc. initiated a voluntary Class III recall for its Cortisol Assay Kit (Chemiluminescence Method) due to potential cross-contamination. The manufacturer identified that specific batch number 831755 of the kit, registered under National Medical Device Registration Certificate No. 20152403746 in China, could lead to inaccurate patient results, specifically false low cortisol readings, by up to 16%. The issue was internally confirmed by Beckman Coulter and reported on October 11, 2018, with the National Medical Products Administration (NMPA) publishing the recall information on November 7, 2018. While the recall was initiated globally, impacting regions like the USA and Canada, the affected batch was not sold within China. Therefore, no direct corrective actions were required for distribution within China, and the sales quantity of the affected product in China was zero. Beckman Coulter Trading (China) Co., Ltd. acted as the agent, submitting the required recall event report to the relevant provincial food and drug administration department, ensuring compliance with NMPA regulations regarding medical device safety. The recall ensures the integrity of diagnostic testing using this critical assay.