# China NMPA Product Recall - Fully Automated Biochemical and Immunoassay Analyzer, Fully Automated Immunoassay Analyzer, Fully Automated Immunoassay Analyzer

Source: https://www.globalkeysolutions.net/records/china_product_recall/orsendo-medical-equipment-trading-china-co-ltd/75cd3141-be4a-47f7-b693-9870e2f1094c/
Source feed: China

> China NMPA product recall for Fully Automated Biochemical and Immunoassay Analyzer, Fully Automated Immunoassay Analyzer, Fully Automated Immunoassay Analyzer by Orsendo Medical Equipment Trading (China) Co., Ltd. published August 17, 2020. Recall level: Level 2. Ausendo Medical Devices Trading (China) Co., Ltd. initiated a voluntary Class II recall for several 

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Orsendo Medical Devices Trading (China) Co., Ltd. is voluntarily recalling its fully automated biochemical and immunoassay analyzers, fully automated immunoassay analyzers, and fully automated immunoassay analyzers.
- Company Name: Orsendo Medical Equipment Trading (China) Co., Ltd.
- Publication Date: 2020-08-17
- Product Name: Fully Automated Biochemical and Immunoassay Analyzer, Fully Automated Immunoassay Analyzer, Fully Automated Immunoassay Analyzer
- Recall Level: Level 2
- Recall Reason: Due to a problem with some VITROS analyzers being shut down and restarted, the photometer signal board parameters were not correctly restored to default settings, causing a photometer malfunction and making it impossible to process MicroWell analyses.
- Discovering Company: Orsendo Medical Equipment Trading (China) Co., Ltd.
- Manufacturing Company: Orsendo Medical Equipment Trading (China) Co., Ltd.
- Summary: Ausendo Medical Devices Trading (China) Co., Ltd. initiated a voluntary Class II recall for several models of its fully automated biochemical and immunoassay analyzers. This action, reported on August 17, 2020, through the National Medical Products Administration (NMPA), addresses a critical product malfunction. The core issue affects certain VITROS analyzers where, following a shutdown and subsequent restart, the new photometer signal board parameters fail to correctly revert to their default settings. This defect results in a photometer malfunction, specifically preventing the processing of MicroWell analyses, which are crucial for diagnostic testing. The affected devices are identified by Registered Medical Device Registration Numbers: 20173406577, 20173406574, and 20163400357. Detailed information concerning specific product models, specifications, and batch numbers is available in the accompanying "Medical Device Recall Report Form." This proactive recall by Ausendo highlights adherence to regulatory standards set by the NMPA, ensuring patient safety and product reliability in the medical device sector.

Company: https://www.globalkeysolutions.net/companies/orsendo-medical-equipment-trading-china-co-ltd/9d283785-b2ea-4291-8250-5927daf06726/