China NMPA Product Recall - MEN C-type blood rheology dynamic analyzer

On November 29, 2017, Shandong Meiyilin Electronic Instruments Co., Ltd. announced a voluntary Level III recall for its MEN-C Type Blood Rheology Dynamic Analyzer, a medical device used for blood rheology testing. This action was taken due to a significant non-compliance: the product's nameplate markings failed to meet the specific requirements outlined in GB4793.1-2007 Part 5, Marking and Documentation 5.1.3c). This regulatory violation, identified by the company, affected seven batches, encompassing 70 units, of the device (Registration/Filing No.: Lu Shi Yao Jian Xie (Zhun) Zi 2014 No. 2400061) distributed in China. Operating under the regulatory framework of the National Medical Products Administration (NMPA), the company promptly initiated a series of required corrective actions. Firstly, all distributors carrying the affected product batches were mandated to immediately halt sales. Secondly, for units already sold to medical facilities, engineers from Shandong Meiyilin Electronic Instruments Co., Ltd., in collaboration with their distributors, were designated to conduct on-site replacements of the non-compliant machine nameplates. To ensure accountability and proper disposal, all removed nameplates were to be subsequently destroyed by the company's Quality Management Department, thereby addressing the identified marking deficiency and restoring regulatory compliance.