# China NMPA Product Recall - Fully automated biochemical analyzer

Source: https://www.globalkeysolutions.net/records/china_product_recall/roche-diagnostics-products-shanghai-co-ltd/6940cc0c-f11a-4cb7-8d38-dfa7f58f9dea/
Source feed: China

> China NMPA product recall for Fully automated biochemical analyzer by Roche Diagnostics Products (Shanghai) Co., Ltd. published June 19, 2017. Recall level: Level 2 Recall. Roche Diagnostics Products (Shanghai) Co., Ltd. initiated a voluntary Class II recall of its fully a

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Roche Diagnostics Products (Shanghai) Co., Ltd. is voluntarily recalling its fully automated biochemical analyzer.
- Company Name: Roche Diagnostics Products (Shanghai) Co., Ltd.
- Publication Date: 2017-06-19
- Product Name: Fully automated biochemical analyzer
- Recall Level: Level 2 Recall
- Recall Reason: The product software has defects that may cause product malfunctions.
- Discovering Company: Roche Diagnostics Products (Shanghai) Co., Ltd.
- Manufacturing Company: Roche Diagnostics Products (Shanghai) Co., Ltd.
- Summary: Roche Diagnostics Products (Shanghai) Co., Ltd. initiated a voluntary Class II recall of its fully automated biochemical analyzer, as announced by the National Medical Products Administration (NMPA) on June 19, 2017. The recall was prompted by the discovery of a software defect within the product, which could lead to potential malfunctions during operation. This issue affects devices registered under CFDA No. 2012 No. 2403923 and CMI Import Registration No. 20162402938. The company proactively reported the defect and commenced the recall to address the potential impact on product performance and patient safety. A Class II recall indicates that the product may cause temporary or medically reversible adverse health consequences, or that the probability of serious adverse health consequences is remote. The specific models, specifications, and batch numbers of the affected analyzers are detailed in the accompanying "Medical Device Recall Event Report Form." This action underscores the company's commitment to product quality and patient safety, operating under the regulatory oversight of the NMPA. Manufacturers are required to report and address product issues promptly to ensure the integrity of medical devices distributed within the market. The recall ensures that all affected units are identified and corrective measures are taken to prevent potential operational disruptions caused by the identified software flaw.

Company: https://www.globalkeysolutions.net/companies/roche-diagnostics-products-shanghai-co-ltd/9b830c5b-8305-4f55-9e76-759151e7c7a9/