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 for several models of its fully automated biochemical and immunoassay analyzers. This action, reported on August 17, 2020, through the National Medical Products Administration (NMPA), addresses a critical product malfunction. The core issue affects certain VITROS analyzers where, following a shutdown and subsequent restart, the new photometer signal board parameters fail to correctly revert to their default settings. This defect results in a photometer malfunction, specifically preventing the processing of MicroWell analyses, which are crucial for diagnostic testing. The affected devices are identified by Registered Medical Device Registration Numbers: 20173406577, 20173406574, and 20163400357. Detailed information concerning specific product models, specifications, and batch numbers is available in the accompanying "Medical Device Recall Report Form." This proactive recall by Ausendo highlights adherence to regulatory standards set by the NMPA, ensuring patient safety and product reliability in the medical device sector.