China NMPA Product Recall - Fully Automated Enzyme Immunoassay System

Bio-Rad Biomedical Products (Shanghai) Co., Ltd. initiated a voluntary Level III recall of 43 units of its Fully Automated Enzyme Immunoassay (ELISA) System (Evolis, P/N89601) in China, as reported to the National Medical Products Administration (NMPA) on February 3, 2017. The recall stems from customer complaints regarding a specific malfunction where the instrument experiences buffer depletion during microplate processing, causing it to pause and potentially leading to invalid test results. This issue posed a concern for user safety and accurate diagnostic output. Under the NMPA's oversight, Bio-Rad is implementing several corrective actions. These include dispatching notification letters to all affected customers via distributors to inform them of the issue and necessary precautions. Additionally, the company will affix warning labels directly onto the front panels of the recalled instruments and update the instruction manuals to include revised warning statements. Crucially, a software revision will be rolled out to address the underlying cause of the buffer depletion malfunction, aiming to prevent recurrence and restore the system's intended performance and safety.