# China NMPA Product Recall - RMK-150 refractometer

Source: https://www.globalkeysolutions.net/records/china_product_recall/shanghai-xiongbo-precision-instruments-co-ltd/516efb56-ab0f-4164-9ba5-4b87058fd40f/
Source feed: China

> China NMPA product recall for RMK-150 refractometer by Shanghai Xiongbo Precision Instruments Co., Ltd. published July 19, 2017. Recall level: Level 3. On July 19, 2017, the National Medical Products Administration (NMPA) announced a voluntary Class II

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Shanghai Xiongbo Precision Instruments Co., Ltd. voluntarily recalls optometry equipment.
- Company Name: Shanghai Xiongbo Precision Instruments Co., Ltd.
- Publication Date: 2017-07-19
- Product Name: RMK-150 refractometer
- Recall Level: Level 3
- Recall Reason: The instruction manual does not include the fuse model and rating.
- Discovering Company: Shanghai Xiongbo Precision Instruments Co., Ltd.
- Manufacturing Company: Shanghai Xiongbo Precision Instruments Co., Ltd.
- Summary: 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.

Company: https://www.globalkeysolutions.net/companies/shanghai-xiongbo-precision-instruments-co-ltd/55bbdccc-5511-49c5-8bff-60fbc590727f/