# China NMPA Product Recall - Fully automated biochemical analyzer; fully automated biochemical immunoassay analyzer; fully automated chemiluminescence immunoassay analyzer

Source: https://www.globalkeysolutions.net/records/china_product_recall/roche-diagnostics-products-shanghai-co-ltd/23e92434-75cc-493f-9e5e-c84d1bff6fa2/
Source feed: China

> China NMPA product recall for Fully automated biochemical analyzer; fully automated biochemical immunoassay analyzer; fully automated chemiluminescence immunoassay analyzer by Roche Diagnostics Products (Shanghai) Co., Ltd. published August 19, 2019. Recall level: Level 2 Recall. Roche Diagnostics Products (Shanghai) Co., Ltd., in collaboration with the National Medical Products

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Roche Diagnostics Products (Shanghai) Co., Ltd. is voluntarily recalling its fully automated biochemical analyzers, fully automated biochemical immunoassay analyzers, fully automated chemiluminescence immunoassay analyzers, and fully automated chemiluminescence immunoassay analyzers.
- Company Name: Roche Diagnostics Products (Shanghai) Co., Ltd.
- Publication Date: 2019-08-19
- Product Name: Fully automated biochemical analyzer; fully automated biochemical immunoassay analyzer; fully automated chemiluminescence immunoassay analyzer
- Recall Level: Level 2 Recall
- Recall Reason: Roche Diagnostics headquarters recently learned of a quality issue with high-pressure solenoid valves from manufacturer Hitachi High Technologies (HHT). Since some Roche Diagnostics instruments use the same high-pressure solenoid valves, they are also affected. Solenoid valve malfunctions are not always detectable, and the possibility that erroneous results are not labeled with data or displayed as system warnings cannot be ruled out.
- Discovering Company: Roche Diagnostics Products (Shanghai) Co., Ltd.
- Manufacturing Company: Roche Diagnostics Products (Shanghai) Co., Ltd.
- Summary: Roche Diagnostics Products (Shanghai) Co., Ltd., in collaboration with the National Medical Products Administration (NMPA), initiated a voluntary Class II recall on August 19, 2019. This action was prompted by a quality issue identified by manufacturer Hitachi High Technologies (HHT) concerning high-pressure solenoid valves used in various Roche Diagnostics instruments. The core problem lies in the potential for these solenoid valves to malfunction, which may not always be detectable by the system. Consequently, there is a risk of generating erroneous patient results without corresponding data labeling or system warnings, posing a significant concern for diagnostic accuracy and patient safety. The recall specifically targets several categories of analytical equipment, including fully automated biochemical analyzers, fully automated biochemical immunoassay analyzers, and fully automated chemiluminescence immunoassay analyzers. Roche Diagnostics Products (Shanghai) Co., Ltd. is actively working to address this issue by recalling the affected units to mitigate any potential adverse impacts on patient care.

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