China NMPA Product Recall - Refractometer, RMK-150

Shanghai Xiongbo Precision Instruments Co., Ltd. initiated a voluntary Class III recall for its Optometristor devices, specifically model RMK-150 (also referred to as PMK-150 or RJK-150). This action, published by the National Medical Products Administration (NMPA) on July 24, 2017, addresses a critical product deficiency. The primary issue identified was the absence of crucial safety information in the instruction manuals; specifically, they failed to specify the model and rated value of the fuse. The recall impacts 307 units of the affected batch sold within China. As a corrective measure, Shanghai Xiongbo Precision Instruments Co., Ltd. is recalling all instruction manuals associated with this particular batch of Optometristors to rectify the information gap. The recall highlights the manufacturer's responsibility under the regulatory framework to ensure comprehensive and accurate product documentation for medical devices.