China NMPA Product Recall - Automated Enzyme Immunoassay Analyzer

Tosoh Corporation, a medical device manufacturer, initiated a voluntary Class III recall for its Automated Enzyme Immunoassay Analyzer, as reported by its subsidiary, Tosoh (Shanghai) Biotechnology Co., Ltd., on July 6, 2021. This significant regulatory action was undertaken due to an identified issue involving the incorrect printing of rated power specifications on the product labels of specific models and batches of the medical device. The affected product is registered under certificate No.: 20152221420. The National Medical Products Administration (NMPA) is the regulatory authority overseeing this recall, ensuring adherence to medical device safety and quality standards in China. A Class III recall typically indicates a situation where use of or exposure to a violative product is not likely to cause adverse health consequences. However, accurate labeling, especially regarding power specifications, is crucial for the safe and correct operation of medical equipment, preventing potential misuse or damage. Tosoh Corporation is taking proactive steps to rectify this labeling discrepancy, and comprehensive details regarding the specific affected models, specifications, and batch numbers are documented within a Medical Device Recall Event Report Form, available for relevant parties. This recall underscores the continuous commitment to product integrity and patient safety within the medical device industry.