# China NMPA Product Recall - Alinity c Fully Automated Biochemical Analyzer

Source: https://www.globalkeysolutions.net/records/china_product_recall/abbott-trading-shanghai-co-ltd/ca2a439f-92db-432f-8770-5e1edcec6293/
Source feed: China

> China NMPA product recall for Alinity c Fully Automated Biochemical Analyzer by Abbott Trading (Shanghai) Co., Ltd. published June 19, 2020. Recall level: Level 3. On June 19, 2020, Abbott Trading (Shanghai) Co., Ltd. initiated a voluntary recall of its Alinity c 

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Abbott Trading (Shanghai) Co., Ltd. is voluntarily recalling the Alinity fully automated biochemical analyzer.
- Company Name: Abbott Trading (Shanghai) Co., Ltd.
- Publication Date: 2020-06-19
- Product Name: Alinity c Fully Automated Biochemical Analyzer
- Recall Level: Level 3
- Recall Reason: The Alinity c optical system may exhibit a nonlinear optical system response, and the diffraction grating within the optical components may cause the absorbance value to be lower than expected.
- Discovering Company: Abbott Trading (Shanghai) Co., Ltd.
- Manufacturing Company: Abbott Trading (Shanghai) Co., Ltd.
- Summary: On June 19, 2020, Abbott Trading (Shanghai) Co., Ltd. initiated a voluntary recall of its Alinity c fully automated biochemical analyzer under the oversight of the National Medical Products Administration (NMPA). The recall, classified as Level III, was prompted by identified performance issues within the device's optical system. Specifically, concerns include a potential for nonlinear optical system response and the diffraction grating component possibly causing absorbance values to be lower than expected. These issues could affect the accuracy and reliability of diagnostic test results. Abbott Trading (Shanghai) Co., Ltd. proactively reported these findings. Detailed information regarding the specific models, specifications, and batches of affected products is available in a supplementary Medical Device Recall Event Report Form. This action underscores the company's commitment to product quality and patient safety, addressing potential inaccuracies in their medical diagnostic equipment to maintain clinical reliability.

Company: https://www.globalkeysolutions.net/companies/abbott-trading-shanghai-co-ltd/851d8fbf-2dac-497e-bf33-820114081013/