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

Source: https://www.globalkeysolutions.net/records/china_product_recall/waters-corporation/d851eba7-cc04-4c0d-9ea7-3b5fec72e2a0/
Source feed: China

> China NMPA product recall for Ultra-high performance liquid chromatography-tandem mass spectrometry system by Waters Corporation published May 30, 2019. Recall level: Level 3 Recall. Waters Corporation (Shanghai) Co., Ltd. initiated a voluntary Class III recall for its Ultra-High Pe

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Waters Technology (Shanghai) Co., Ltd. is voluntarily recalling its ultra-high performance liquid chromatography-tandem mass spectrometry system.
- Company Name: Waters Corporation
- Publication Date: 2019-05-30
- Product Name: Ultra-high performance liquid chromatography-tandem mass spectrometry system
- Recall Level: Level 3 Recall
- Recall Reason: The Xevo TQ-S IVD component of the ACQUITY I-S system does not have a Chinese label on its outer packaging, which does not comply with Chinese regulations.
- Discovering Company: Waters Technology (Shanghai) Co., Ltd.
- Manufacturing Company: Waters Corporation
- Summary: 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."

Company: https://www.globalkeysolutions.net/companies/waters-corporation/06e6a596-1951-41f1-a33f-c633e0f665d5/