China NMPA Product Recall - sheath fluid

The National Medical Products Administration (NMPA) announced a voluntary Class III recall initiated by Bio-Rad Medical Products (Shanghai) Co., Ltd., published on February 21, 2017. The recall concerns the company's Sheath Fluid products. Bio-Rad identified a significant labeling error where an incorrect registration certificate number was printed on the Chinese labels of the affected products. Operating under the regulatory framework of the NMPA, Bio-Rad proactively decided to remove these non-compliant products from the market. A Class III recall indicates that the use of or exposure to the product is unlikely to cause adverse health consequences. Detailed information regarding specific product batches and specifications is available in the 'Medical Device Recall Event Report Form' attachment. This action underscores the necessity for precise product information and strict adherence to local labeling regulations for medical devices distributed under NMPA oversight. Bio-Rad's voluntary recall demonstrates its commitment to rectifying identified discrepancies and maintaining regulatory compliance.