China NMPA Product Recall - Fully automated blood gas analyzer (GEM Premier 3000, 3500, 4000)

Instrumentation Laboratory Co., in collaboration with its agent Wofen Medical Devices Trading (Beijing) Co., Ltd., initiated a Class III voluntary recall of its Fully Automated Blood Gas Analyzers in China. This recall, publicized by the National Medical Products Administration (NMPA) on July 4, 2019, affects GEM Premier 3000, 3500, and 4000 models manufactured after February 27, 2018. The primary issue concerns a labeling discrepancy: the Chinese label on the back of 558 affected units displayed an outdated NMPA registration certificate number, failing to meet current regulatory requirements. Operating under the NMPA's framework for medical device oversight, the company has prescribed specific corrective actions. Instrumentation Laboratory Co. is providing accurate supplementary labels. Wofen Medical Devices Trading (Beijing) Co., Ltd. is responsible for distributing field safety notices and these supplementary labels to all affected distributors. Furthermore, the agent must ensure all incorrect labels on products in their inventory and at customer locations are promptly updated with the correct NMPA registration information, thereby ensuring regulatory compliance.