China NMPA Product Recall - Fully Automated Enzyme Immunoassay System

Bio-Rad Biomedical Products (Shanghai) Co., Ltd., on behalf of manufacturer Bio-Rad Laboratories, Inc., initiated a voluntary Level III recall for 43 units of its Fully Automated Enzyme Immunoassay (ELISA) Systems, model EVOLIS (P/N89601), in China. The recall, reported to the National Medical Products Administration (NMPA) on February 3, 2017, and published on February 21, 2017, addresses a critical product malfunction. The primary issue stems from the Evolis instrument's buffer depletion during microplate processing. This malfunction can cause the instrument to pause while microplate transfer continues, potentially leading to invalid test results and posing a safety risk to users if the bottom drawer is accessed improperly. Customer complaints prompted this proactive measure. To mitigate these issues and enhance user safety, Bio-Rad is implementing several corrective actions. These include distributing notification letters to all affected customers via distributors, applying warning labels directly to the instruments' front panels, updating warning statements within the instruction manuals, and revising the system's software. These actions aim to inform users of the potential hazard and prevent further incidents, ensuring the integrity of test results and operational safety.