# China NMPA Product Recall - Fully automated biochemical analyzer

Source: https://www.globalkeysolutions.net/records/china_product_recall/roche-diagnostics-products-shanghai-co-ltd/a4603411-777d-4a81-a2ce-a444ec8ed6c8/
Source feed: China

> China NMPA product recall for Fully automated biochemical analyzer by Roche Diagnostics Products (Shanghai) Co., Ltd. published July 26, 2019. Recall level: Level 2 Recall. Hitachi Diagnostic Products (Shanghai) Co., Ltd., under the oversight of the National Medical Produc

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Hitachi Diagnostics Products (Shanghai) Co., Ltd. is voluntarily recalling its fully automated biochemical analyzer.
- Company Name: Roche Diagnostics Products (Shanghai) Co., Ltd.
- Publication Date: 2019-07-26
- Product Name: Fully automated biochemical analyzer
- Recall Level: Level 2 Recall
- Recall Reason: Due to manufacturing process issues, the solenoid valves inside the instrument may malfunction and fail to open or close properly, leading to problems such as abnormal liquid level detection alarms, sample and reagent contamination causing abnormal measurement data, or overflow of cleaning water.
- Discovering Company: Hitachi Diagnostics Products (Shanghai) Co., Ltd.
- Manufacturing Company: Roche Diagnostics Products (Shanghai) Co., Ltd.
- Summary: Hitachi Diagnostic Products (Shanghai) Co., Ltd., under the oversight of the National Medical Products Administration (NMPA) and the Shanghai Food and Drug Administration, initiated a voluntary Level II recall of its Fully Automated Biochemical Analyzers. This action, published on July 26, 2019, addresses a critical manufacturing defect in solenoid valves, components supplied by Hitachi High Technology Co., Ltd. of Japan.

The core issue involves the solenoid valves malfunctioning, failing to properly open or close. This directly impacts the instrument's internal cleaning water flow path for sample and reagent needles and the water pressure regulation for the gear pump. Such malfunctions can trigger alarms for abnormal liquid level detection. More significantly, they risk contaminating samples and reagents due to improper cleaning water drainage, leading to inaccurate measurement data. Conversely, continuous cleaning water discharge could cause overflow into critical areas like moving tracks or reaction vessels, further compromising data integrity.

To mitigate these risks, the company is recalling specific batches of affected analyzers, including those with registration certificate numbers 20172400678, 20172401042, and 20162400621. Detailed information on models and batches is available in an attached Medical Device Recall Event Report Form. This voluntary recall ensures adherence to medical device safety standards under NMPA regulations.

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