China NMPA Product Recall - Refractometer, RMK-150

Shanghai Xiongbo Precision Instruments Co., Ltd. initiated a Class III voluntary recall of its Optometristors (models RMK-150 and RJK-150) on August 8, 2017, under the oversight of the National Medical Products Administration (NMPA). The core issue identified was a critical omission in the product instruction manuals, which failed to specify the model and rated value of the fuse. This deficiency in the user documentation affects safety information for a device designed to measure human eye refractive power. As a required action under the NMPA's regulatory framework, the company is recalling all instruction manuals for the affected batch of RJK-150 optometrists to rectify the missing fuse details. This measure ensures users receive complete and accurate operational and safety documentation. The recall involved 307 units of Optometrist PMK-150 sold in China, reflecting the company's commitment to compliance and product safety through transparent reporting and corrective actions.