# China NMPA Product Recall - Chemiluminescence immunoassay analyzer

Source: https://www.globalkeysolutions.net/records/china_product_recall/siemens-medical-diagnostics-products-shanghai-co-ltd/0457c0dc-4dc5-47f6-b73d-9b6bc42cc946/
Source feed: China

> China NMPA product recall for Chemiluminescence immunoassay analyzer by Siemens Medical Diagnostics Products (Shanghai) Co., Ltd. published May 22, 2020. Recall level: Level 3 Recall. Siemens Medical Diagnostics Products (Shanghai) Co., Ltd. initiated a voluntary Class III recall for

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Siemens Medical Diagnostics Products (Shanghai) Co., Ltd. is voluntarily recalling the IMMULITE 2000 XPi Automated Immunoassay Analyzer.
- Company Name: Siemens Medical Diagnostics Products (Shanghai) Co., Ltd.
- Publication Date: 2020-05-22
- Product Name: Chemiluminescence immunoassay analyzer
- Recall Level: Level 3 Recall
- Recall Reason: During routine maintenance, the hose connecting the waste liquid bottle to the product may break. Waste liquid may leak onto the floor, posing a potential hazard of slipping or falling.
- Discovering Company: Siemens Medical Diagnostics Products (Shanghai) Co., Ltd.
- Manufacturing Company: Siemens Medical Diagnostics Products (Shanghai) Co., Ltd.
- Summary: Siemens Medical Diagnostics Products (Shanghai) Co., Ltd. initiated a voluntary Class III recall for its Chemiluminescence Immunoassay Analyzer and IMMULITE 2000 XPi Automated Immunoassay Analyzer. Announced on May 22, 2020, through the National Medical Products Administration (NMPA), this action addresses a critical safety concern identified during routine maintenance. The primary issue involves the potential breakage of the hose connecting the waste liquid bottle, which can lead to leaks. Such leaks pose a significant safety hazard, specifically increasing the risk of slipping or falling for personnel operating or near the equipment. The regulatory framework governing this recall is the NMPA, which has classified it as a Class III recall. The required actions by Siemens involve the voluntary retrieval of the affected medical devices. Specific details regarding the impacted product models, specifications, and batch numbers are provided in the "Medical Device Recall Event Report Form," which customers are directed to consult. This proactive recall demonstrates the company's commitment to ensuring the safety and reliability of its medical diagnostic equipment and adherence to national medical device regulations.

Company: https://www.globalkeysolutions.net/companies/siemens-medical-diagnostics-products-shanghai-co-ltd/deadd648-fc6f-4bb3-90c6-57b16497a6e9/