China NMPA Product Recall - High-density lipoprotein cholesterol test kit (direct method) Cholestest N HDL

Sekisui Medical Co., Ltd., in collaboration with its Chinese subsidiary, Sekisui Medical Technology (China) Co., Ltd., has initiated a voluntary Class III recall concerning its High-Density Lipoprotein Cholesterol Test Kit (Direct Method), known as Cholestest N HDL. This regulatory action was formally reported to the National Medical Products Administration (NMPA) on November 15, 2024. The primary reason for this recall originates from necessary adjustments in the domestic labeling information for the product within Japan. The affected diagnostic kit, registered under National Medical Device Registration Certificate No. 20162401433, is a critical component for cholesterol level assessment. Importantly, Sekisui Medical Technology (China) Co., Ltd. has confirmed that the specific models, specifications, and batches identified in this recall were not imported into the People's Republic of China. This notification to the NMPA demonstrates the company's commitment to regulatory compliance and transparency, even when the direct market impact of the recall is contained to other geographical regions. The "Medical Device Recall Event Report Form" provides comprehensive details about the specific products involved, ensuring that all relevant information is accessible to regulatory bodies. This proactive measure ensures global product integrity standards are maintained.