# China NMPA Product Recall - Fully Automated Fluorescence Immunoassay Analyzer

Source: https://www.globalkeysolutions.net/records/china_product_recall/thermo-fisher-scientific-china-co-ltd/065c259e-066c-4d0a-b46d-938483fe1b1f/
Source feed: China

> China NMPA product recall for Fully Automated Fluorescence Immunoassay Analyzer by Thermo Fisher Scientific (China) Co., Ltd. published November 13, 2017. Recall level: Level 3. Thermo Fisher Scientific (China) Co., Ltd. initiated a voluntary Class III recall of its fully autom

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Thermo Fisher Scientific (China) Co., Ltd. is voluntarily recalling its fully automated fluorescence immunoassay analyzer.
- Company Name: Thermo Fisher Scientific (China) Co., Ltd.
- Publication Date: 2017-11-13
- Product Name: Fully Automated Fluorescence Immunoassay Analyzer
- Recall Level: Level 3
- Recall Reason: An erroneous liquid level sensor in the product may lead to incorrect detection results.
- Discovering Company: Thermo Fisher Scientific (China) Co., Ltd.
- Manufacturing Company: Thermo Fisher Scientific (China) Co., Ltd.
- Summary: Thermo Fisher Scientific (China) Co., Ltd. initiated a voluntary Class III recall of its fully automated fluorescence immunoassay analyzer, as reported by the National Medical Products Administration (NMPA) on November 13, 2017. The recall was prompted by a critical issue involving an error in the liquid level sensor within the affected product. This sensor malfunction has the potential to produce inaccurate test results, posing a risk to diagnostic reliability. The company is taking proactive steps to address this deficiency, ensuring compliance with regulatory standards set by the NMPA. The recall encompasses specific models, specifications, and batch numbers of the analyzer, detailed in the 'Medical Device Recall Event Report Form' and its 'Recalled Product List' attachment. This action underscores Thermo Fisher Scientific's commitment to product safety and regulatory adherence under the NMPA's oversight, aiming to mitigate any potential impact on patient care or diagnostic accuracy.

Company: https://www.globalkeysolutions.net/companies/thermo-fisher-scientific-china-co-ltd/580e6795-f6cb-4d91-afd1-d1d8602f0dca/