China NMPA Product Recall - Transport culture medium

On August 9, 2021, Shanghai Kemajia Microbial Technology Co., Ltd. initiated a voluntary Level III recall of its transport culture medium (Registration Certificate No.: "沪虹械备20200001号"). This action followed reports from Hangzhou Central Hospital and Hangzhou Dingqiao Hospital, highlighting critical quality deficiencies. Specifically, five virus sampling tubes were discovered to contain mold at the spiral end and black flocculent matter within the preservation solution. The National Medical Products Administration (NMPA) and the Shanghai Municipal Drug Administration are involved in overseeing this regulatory event. The presence of such contaminants in a medical device like transport culture medium raises concerns about sample integrity and potential patient safety risks. A Level III recall indicates that the use of or exposure to the affected product is unlikely to cause adverse health consequences. Shanghai Kemajia Microbial Technology Co., Ltd. is undertaking this recall to address the identified product quality issues, with comprehensive details on affected models, specifications, and batches provided in the "Medical Device Recall Event Report Form." This measure demonstrates the company's commitment to product safety and public health standards.