China NMPA Product Recall - Washing solution/diluent

Bio-Rad Medical Products (Shanghai) Co., Ltd. initiated a voluntary Class III recall of its Washing Solution and Diluent products, as reported to the National Medical Products Administration (NMPA) on July 3, 2017, and publicly announced on July 27, 2017. The recall specifically targets products from batch number 64080534, affecting approximately 200 units imported, with 162 pieces sold in China. The primary issue stemmed from an error on the Chinese labels of the affected products, where an incorrect registration certificate number was displayed. This labeling inaccuracy, while not presenting a direct health risk, required immediate corrective actions under the NMPA's regulatory framework for medical devices. Bio-Rad implemented a two-part resolution strategy: all in-stock products had their shipments frozen and were subsequently corrected with accurate labels before release. For products already shipped to customers, Bio-Rad committed to distributing recall letters through its distributors, providing customers with the correct labels to perform the necessary on-site corrections, ensuring full compliance with regulatory standards.