China NMPA Product Recall - sheath fluid

Bio-Rad Life Sciences (Shanghai) Co., Ltd. initiated a voluntary Level III recall of its Sheath Fluid product in China, as reported to the National Medical Products Administration (NMPA) on February 3, 2017, and publicly announced on February 21, 2017. The recall was prompted by the discovery that the Chinese labels on products from batch number AA60077 contained an incorrect registration certificate number. The manufacturer, Bio-Rad Laboratories, Inc., through its Chinese unit, identified this labeling discrepancy after receiving customer complaints. The affected product, identified by Registration Certificate Number CFDA (Imported) No. 20131401036, is designed for use in flow cytometry to form sheath fluid. A total of 18 boxes, each containing 4 liters, were impacted and sold within China, with no remaining stock at the time of the report. In response to this labeling error, Bio-Rad's required actions included promptly notifying all affected customers. Furthermore, the company provided the correct labels to these customers to facilitate the necessary label corrections on the products. This proactive measure aims to ensure compliance with Chinese regulatory standards under the NMPA framework.