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

Aussendo Medical Devices Trading (China) Co., Ltd. initiated a voluntary Class II recall for its fully automated biochemical and immunoassay analyzers, fully automated immunoassay analyzers, and fully automated immunoassay analyzers. This action, reported on March 8, 2019, falls under the regulatory oversight of the National Medical Products Administration (NMPA) and the Shanghai Food and Drug Administration. The recall addresses a significant product performance issue stemming from a potential malfunction in some VITROS analyzers. Specifically, after a shutdown and subsequent restart, the new photometer signal board parameters may not properly revert to their default settings. This defect could lead to a photometer malfunction, rendering MicroWell analysis impossible and impacting the diagnostic capability of the devices. The affected products include devices with Registration Certificate Nos.: 20173406577, 20173406574, and 20163400357. Detailed information regarding specific models, specifications, and batch numbers is available in the associated "Medical Device Recall Event Report Form." This proactive recall by Aussendo demonstrates their commitment to product safety and adherence to regulatory standards.