China NMPA Product Recall - RMK-150 refractometer

On July 19, 2017, the National Medical Products Administration (NMPA) announced a voluntary Class III recall initiated by Shanghai Xiongbo Precision Instruments Co., Ltd. for its Optometristor, specifically the Refractometer RMK-150. The primary issue identified was a critical omission in the product documentation: the instruction manuals for these medical devices (Registration No.: 沪食药监械(2221247号)) failed to specify the model and rating of the fuses. This represents a significant regulatory non-compliance, as complete and accurate fuse information is vital for ensuring device safety, proper maintenance, and preventing potential hazards. The recall affects 307 units of the Refractometer RMK-150, identified across batches CP-RMK-15000555/307 and CP-RMK-15000555, which were sold in China. As a required corrective action under NMPA guidelines, Shanghai Xiongbo Precision Instruments Co., Ltd. is mandated to recall all instruction manuals associated with the identified batch of Refractometer RMK-150 to rectify this documentation deficiency. This action aims to ensure that all users and service personnel have access to complete and accurate operational and safety information.