# 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/229e3c55-4e6b-4bba-95e6-175748f129a5/
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 March 11, 2019. Recall level: Level 2 Recall. Ausendo Medical Devices Trading (China) Co., Ltd. initiated a voluntary Class II recall of its fully

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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: 2019-03-11
- Product Name: Fully Automated Biochemical and Immunoassay Analyzer, Fully Automated Immunoassay Analyzer, Fully Automated Immunoassay Analyzer
- Recall Level: Level 2 Recall
- Recall Reason: After some VITROS analyzers are shut down and restarted, the photometer malfunctions because the parameters of the new photometer signal board are not correctly restored to default settings, resulting in the inability 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 of its fully automated biochemical and immunoassay analyzers, including models registered under NMPA numbers 20173406577, 20173406574, and 20163400357. The recall, announced by the National Medical Products Administration (NMPA) on March 11, 2019, addresses a critical issue with some VITROS analyzers. The primary concern is a photometer malfunction occurring after the analyzers are shut down and subsequently restarted. Specifically, the parameters of the new photometer signal board fail to correctly restore to their default settings, which consequently prevents the processing of MicroWell analyses. The company is taking this action to mitigate potential risks associated with the device's performance. Affected product models, specifications, and batch details are elaborated in the "Medical Device Recall Report Form," which provides comprehensive information for stakeholders regarding the scope of the recall. This voluntary recall emphasizes the company's commitment to product safety and compliance with regulatory standards set by the NMPA.

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