China NMPA Product Recall - Fully Automated Enzyme Immunoassay System

Bio-Rad Life Sciences (Shanghai) Co., Ltd., on behalf of its manufacturer Bio-Rad Laboratories, Inc., initiated a voluntary Level III recall for its "Fully Automated Enzyme Immunoassay (ELISA) System," specifically the EVOLIS instrument (P/N89601). The recall was reported on February 3, 2017, and publicly announced by the National Medical Products Administration (NMPA) on February 21, 2017.

The primary issue identified involved system malfunctions during operation, potentially leading to invalid test results. Customer complaints detailed instances where buffer depletion caused the instrument to pause, necessitating careful manual intervention during microplate transfer. This defect impacted the reliability and accuracy of diagnostic procedures.

Operating under the regulatory oversight of the NMPA, referencing CFDA Imported registration number 20123404090, the recall affects 43 units that were imported and sold in China. To address these concerns and enhance user safety, Bio-Rad is implementing several corrective actions. These include directly notifying affected customers and distributors, affixing new warning labels to the instruments, updating relevant warning statements in the instruction manuals, and revising the system's software. These measures aim to resolve the identified performance and safety issues.