China NMPA Product Recall - Substrate solutions for fully automated immunoassay systems

Ausendo Medical Devices Trading (China) Co., Ltd. initiated a voluntary Class III recall of its substrate solution for a fully automated immunoassay testing system on October 11, 2017. The recall was prompted by an identified issue where the testing system associated with the affected product might fail to detect the bottom of the reagent, potentially leading to inaccurate test results. The specific product involved is a fully automated immunoassay testing system with Registration No.: 20150743. This action falls under the regulatory oversight of the National Medical Products Administration (NMPA) of China. Further detailed information, including specific models, specifications, and batch numbers of the affected products, is available in the 'Medical Device Recall Event Report Form' attachment. The company has taken this measure to address the potential quality concern and ensure product safety.