China NMPA Product Recall - Free thyroxine assay kit (enzyme-linked fluorescence method)

bioMérieux Diagnostics (Shanghai) Co., Ltd., acting as agent for manufacturer bioMerieux, SA, initiated a voluntary Class II recall for its Free Thyroxine Assay Kit (Enzyme-Linked Fluorescence Assay), identified by Registration No.: CFDA (Imported) 2014 No. 2403542. This action, documented by the National Medical Products Administration (NMPA) on July 27, 2017, addresses a significant product quality issue. The core problem, affecting batch number 100529119, involved a defect in the conjugate component. This flaw resulted in an abnormally low relative fluorescence value, leading to inaccurate diagnostic test results. While the initial customer complaints originated from outside mainland China, the recall specifically impacted 30 boxes of the product sold within China. To rectify the issue and safeguard patient health, bioMérieux implemented several corrective actions. These included instructing all affected customers to immediately cease using the compromised batch. Furthermore, the company committed to replacing the faulty products and mandated the scrapping of all existing inventory of the defective kits, ensuring no unreliable diagnostic tools remain in circulation.