China NMPA Product Recall - Fully automated immunoassay analyzer, fully automated biochemical analyzer, fully automated biochemical immunoassay analyzer

Ausendo Medical Devices Trading (China) Co., Ltd. initiated a voluntary Class II recall for specific medical devices, as announced by the National Medical Products Administration (NMPA) on December 11, 2018. The recall involves their Fully Automated Immunoassay Analyzer, Fully Automated Biochemical Analyzer, and Fully Automated Biochemical Immunoassay Analyzer product lines. The primary issue identified is a potential malfunction where the analyzers may erroneously prolong the onboard stability time of reagents. This defect could compromise the accuracy and reliability of diagnostic test results, posing a risk to patient care. Operating under the regulatory oversight of the NMPA and specifically noted by the Shanghai Food and Drug Administration, Ausendo voluntarily took action to address this product deficiency. While no specific inspection dates are cited, the recall process reflects adherence to established medical device regulations in China. The required action by the company is the voluntary recall of affected units. Further details, including specific product models, specifications, and batch information, are documented in an accompanying "Medical Device Recall Event Report Form" provided by the company to the regulatory bodies. This action aims to mitigate potential risks associated with inaccurate diagnostic readings.