China NMPA Product Recall - Ultra-high performance liquid chromatography-tandem mass spectrometry system

Waters Corporation (Shanghai) Co., Ltd. initiated a voluntary Class III recall for its Ultra-High Performance Liquid Chromatography-Tandem Mass Spectrometry System, specifically components of the ACQUITY I-S system. This action, reported on May 30, 2019, addresses a significant labeling non-compliance. The primary issue identified was the absence of Chinese labels on the outer packaging of the imported Xevo TQ-S IVD components. This oversight meant the product did not comply with mandatory Chinese regulatory requirements for medical device labeling.

To resolve the violation, Waters Corporation committed to re-affixing appropriate Chinese labels to the outer packaging of all affected triple quadrupole tandem mass spectrometer components. Waters Technology (Shanghai) Co., Ltd., acting as the company's designated agent in China, is overseeing the voluntary recall process. This proactive measure ensures that the product's labeling meets national standards, reflecting the company's dedication to regulatory adherence and proper information dissemination within the Chinese market. Further specifics regarding affected product models and batches are available in the official "Medical Device Recall Event Report Form."