China NMPA Product Recall - Fully Automated Biochemical and Immunoassay Analyzer, Fully Automated Immunoassay Analyzer, Fully Automated Immunoassay Analyzer

Ausendo Medical Devices Trading (China) Co., Ltd. initiated a voluntary Class II recall of its fully automated biochemical and immunoassay analyzers, including models registered under NMPA numbers 20173406577, 20173406574, and 20163400357. The recall, announced by the National Medical Products Administration (NMPA) on March 11, 2019, addresses a critical issue with some VITROS analyzers. The primary concern is a photometer malfunction occurring after the analyzers are shut down and subsequently restarted. Specifically, the parameters of the new photometer signal board fail to correctly restore to their default settings, which consequently prevents the processing of MicroWell analyses. The company is taking this action to mitigate potential risks associated with the device's performance. Affected product models, specifications, and batch details are elaborated in the "Medical Device Recall Report Form," which provides comprehensive information for stakeholders regarding the scope of the recall. This voluntary recall emphasizes the company's commitment to product safety and compliance with regulatory standards set by the NMPA.