China NMPA Product Recall - Fully automated biochemical analyzer

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.