China NMPA Product Recall - High-density lipoprotein cholesterol assay kit (direct method) QUICKAUTO NEO HDL-C

The National Medical Products Administration (NMPA) reported a voluntary Class III recall initiated by Shino-Test Corporation (Japan) for its High-Density Lipoprotein Cholesterol Assay Kit (Direct Method) QUICKAUTO NEO. The recall, published on November 13, 2024, was prompted by revisions made to the product's Japanese labeling. While the specific inspection dates are not provided in this document, the manufacturer proactively addressed the labeling changes. Hitachi Diagnostics Products (Shanghai) Co., Ltd. communicated the recall, confirming that the affected products, identified by National Medical Device Registration Certificate No. 20152400907, were not imported into China. This action ensures that all product information aligns with current standards, demonstrating the company's commitment to regulatory compliance and product integrity within its markets of distribution, specifically excluding China in this instance. Further details regarding specific models are referenced in an attached Medical Device Recall Event Report Form.