China NMPA Product Recall - Fully automated biochemical analyzer

Jiangsu Kelundi Medical Technology Co., Ltd. has initiated a voluntary Level III recall for four units of its Fully Automated Biochemical Analyzer. Publicly reported on April 25, 2021, the recall addresses incorrect nameplate markings on specific units identified by serial numbers FA2LM003, FA2LM005, FA2LM004, and FA2LS001. The company explicitly stated that this labeling discrepancy does not affect the instrument's detection performance or operational functionality.

This action is overseen by the National Medical Products Administration (NMPA) and the Jiangsu Provincial Drug Administration. Jiangsu Kelundi Medical Technology Co., Ltd. fulfilled its regulatory obligations by submitting a Medical Device Recall Event Report Form. Required actions involve the company distributing recall notices to affected users and implementing appropriate handling methods, including engineer support, to rectify the labeling error on the recalled devices. This voluntary recall emphasizes the company's commitment to maintaining accurate product information, even when product functionality is uncompromised.