China NMPA Product Recall - Quality control material/focusing solution for urine formed elements analysis

Beckman Coulter Trading (China) Co., Ltd. initiated a voluntary Class III recall on January 4, 2019, concerning its Urine Formed Components Analysis Quality Control Material/Focusing Solution. The primary issue identified was a critical documentation error: a missing character in the product name as presented in the Chinese instructions for use. This oversight, though seemingly minor, could potentially lead to confusion regarding product identification or usage, highlighting the importance of precise labeling for medical devices. The National Medical Products Administration (NMPA) published this recall, underscoring the company's commitment to addressing quality issues promptly and transparently. While specific inspection dates leading to this discovery are not provided in this public notice, the effective date of the recall, January 4, 2019, indicates the commencement of corrective actions. The regulatory framework governing this recall is the NMPA's comprehensive medical device management system, which mandates strict adherence to labeling and instructional accuracy to safeguard public health. As a required action, Beckman Coulter was tasked with retrieving all affected product models, specifications, and batch numbers, as detailed in the 'Medical Device Recall Event Report Form,' to rectify the labeling deficiency and ensure full compliance with established regulatory standards for medical devices in China.