China NMPA Product Recall - Blood gas, blood oxygen, electrolyte and metabolite analyzer

On March 21, 2019, Radiomet Medical Equipment (Shanghai) Co., Ltd. initiated a voluntary Class III recall for its blood gas, blood oxygen, electrolyte, and metabolite analyzers. This action was taken due to a significant labeling non-conformance, specifically the absence of the registrant's required Chinese name on the product's Chinese label.The recall was reported through the Shanghai Food and Drug Administration Medical Device Recall Notice 2019-072, under the oversight of the National Medical Products Administration (NMPA). The affected products, bearing Registration Certificate No.: CFDA (Imported) 2014 No. 2403525, were identified as lacking essential information required for proper product identification and compliance with local regulatory standards.A Class III recall indicates a situation where use of or exposure to a violative product is not likely to cause adverse health consequences. Radiomet Medical Equipment (Shanghai) Co., Ltd. is responsible for managing the recall process, including identifying and retrieving affected batches as detailed in the "Medical Device Recall Event Report Form." This voluntary recall underscores the importance of strict adherence to labeling regulations to ensure product compliance and consumer safety within the medical device market regulated by the NMPA.