# China NMPA Product Recall - Fully automated blood typing analyzer

Source: https://www.globalkeysolutions.net/records/china_product_recall/orsendo-medical-equipment-trading-china-co-ltd/0b378092-480f-4a77-b7dd-1d6f8a86882b/
Source feed: China

> China NMPA product recall for Fully automated blood typing analyzer by Orsendo Medical Equipment Trading (China) Co., Ltd. published November 10, 2021. Recall level: Level 3 Recall. Ausendo Medical Devices Trading (China) Co., Ltd. initiated a voluntary Level III recall of its full

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Orsendo Medical Devices Trading (China) Co., Ltd. is voluntarily recalling its fully automated blood typing analyzer.
- Company Name: Orsendo Medical Equipment Trading (China) Co., Ltd.
- Publication Date: 2021-11-10
- Product Name: Fully automated blood typing analyzer
- Recall Level: Level 3 Recall
- Recall Reason: In rare cases, abnormalities may occur during the installation of MOD 52 software on the fully automated blood typing analyzer.
- 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 Level III recall of its fully automated blood typing analyzers on November 10, 2021. This action, reported by the Shanghai Municipal Drug Administration and overseen by the National Medical Products Administration (NMPA), addresses a critical issue identified with the devices. The primary concern involves potential malfunctions that can occur during the installation process of the MOD 52 software. While the document does not specify inspection dates, the recall date signifies the company's response to this identified product defect. The affected products, bearing Registration Certificate Nos. 20173402376 and 20173402355, are being recalled to mitigate any risks associated with these software installation failures. Detailed information regarding specific models, specifications, and batch numbers is available in the accompanying "Medical Device Recall Event Report Form." This recall underscores the importance of product safety and compliance within the regulatory framework governing medical devices in China.

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