China NMPA Product Recall - sheath fluid

Bio-Rad Medical Products (Shanghai) Co., Ltd. initiated a Level III voluntary recall in China for its Sheath Fluid product, as reported to the National Medical Products Administration (NMPA) on February 3, 2017. The recall was prompted by the discovery of an incorrect registration certificate number printed on the Chinese labels of the Sheath Fluid reagent kits, specifically batch number AA60077. This issue, which affected 18 boxes imported and sold in China, was identified following customer complaints. Under the regulatory framework of the NMPA (previously CFDA), the company’s required actions included immediately notifying all affected customers and providing them with correct labels for implementation of the necessary label corrections. This proactive measure demonstrates Bio-Rad's commitment to ensuring product compliance and addressing labeling discrepancies in accordance with Chinese medical device regulations.