China NMPA Product Recall - RMK-150 refractometer

Shanghai Xiongbo Precision Instruments Co., Ltd. initiated a voluntary Class III product recall for its Optometristor RMK-150, with the event reported on August 8, 2017. This action was conducted under the regulatory framework of China's National Medical Products Administration (NMPA). The core issue prompting the recall was a deficiency in the product's instruction manual; specifically, it failed to include the model and rated value for the device's fuse. This omission is a significant non-compliance that could potentially lead to improper servicing or incorrect fuse replacement, although a Class III recall typically indicates that the probability of serious adverse health consequences is remote. The recall impacts 307 units of the Optometristor RMK-150 from batch number CP-RMK-15000555. To address this violation, Shanghai Xiongbo Precision Instruments Co., Ltd. is undertaking the required action of recalling all affected instruction manuals from this specific batch. The objective of this corrective measure is to ensure that updated manuals containing the complete and correct fuse specifications are provided, thereby ensuring user safety and adherence to product information standards. This demonstrates the company's commitment to regulatory compliance and user information integrity.