China NMPA Product Recall - Fully automated biochemical analyzer

The National Medical Products Administration (NMPA) announced on June 19, 2017, that Hitachi High Technologies, Inc. of Japan, in conjunction with its Chinese subsidiary, Hitachi High Technologies (Shanghai) International Trading Co., Ltd., initiated a voluntary Class III recall of its fully automated biochemical analyzer. The recall stems from a critical malfunction identified in the liquid level detection sensor's connector. This defect prevents the sample needle from accurately detecting liquid levels within sample containers, causing it to descend directly to the bottom and trigger an alarm. This issue, impacting devices registered under CFDA (Imported) No. 20142401782, could lead to unreliable test results or operational disruptions, although a Class III recall typically indicates that the probability of serious adverse health consequences is remote. The regulatory framework overseeing this action is the NMPA, which is responsible for medical device oversight in China. Hitachi High Technologies (Shanghai) formally reported the malfunction, leading to the recall. Affected parties are directed to refer to the comprehensive 'Medical Device Recall Event Report Form' for specific details regarding registration numbers, product specifications, and batch numbers. This action ensures compliance with Chinese medical device regulations and addresses a product quality issue proactively.