# 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/2eb745a3-5d03-4301-8a47-ce25de94a996/
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 08, 2019. Recall level: Level 2 Recall. Aussendo Medical Devices Trading (China) Co., Ltd. initiated a voluntary Class II recall for its ful

---

## 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: 2019-03-08
- 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, photometer malfunctions may occur because the parameters of the new photometer signal board have not been correctly restored to default settings, 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: Aussendo Medical Devices Trading (China) Co., Ltd. initiated a voluntary Class II recall for its fully automated biochemical and immunoassay analyzers, fully automated immunoassay analyzers, and fully automated immunoassay analyzers. This action, reported on March 8, 2019, falls under the regulatory oversight of the National Medical Products Administration (NMPA) and the Shanghai Food and Drug Administration. The recall addresses a significant product performance issue stemming from a potential malfunction in some VITROS analyzers. Specifically, after a shutdown and subsequent restart, the new photometer signal board parameters may not properly revert to their default settings. This defect could lead to a photometer malfunction, rendering MicroWell analysis impossible and impacting the diagnostic capability of the devices. The affected products include devices with Registration Certificate Nos.: 20173406577, 20173406574, and 20163400357. Detailed information regarding specific models, specifications, and batch numbers is available in the associated "Medical Device Recall Event Report Form." This proactive recall by Aussendo demonstrates their commitment to product safety and adherence to regulatory standards.

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