China NMPA Product Recall - Chemiluminescence immunoassay analyzer

Siemens Medical Diagnostics Products (Shanghai) Co., Ltd. initiated a voluntary Class III recall for its Chemiluminescence Immunoassay Analyzer and IMMULITE 2000 XPi Automated Immunoassay Analyzer. Announced on May 22, 2020, through the National Medical Products Administration (NMPA), this action addresses a critical safety concern identified during routine maintenance. The primary issue involves the potential breakage of the hose connecting the waste liquid bottle, which can lead to leaks. Such leaks pose a significant safety hazard, specifically increasing the risk of slipping or falling for personnel operating or near the equipment. The regulatory framework governing this recall is the NMPA, which has classified it as a Class III recall. The required actions by Siemens involve the voluntary retrieval of the affected medical devices. Specific details regarding the impacted product models, specifications, and batch numbers are provided in the "Medical Device Recall Event Report Form," which customers are directed to consult. This proactive recall demonstrates the company's commitment to ensuring the safety and reliability of its medical diagnostic equipment and adherence to national medical device regulations.