China NMPA Product Recall - Transport culture medium

Shanghai Kemajia Microbial Technology Co., Ltd. initiated a voluntary Class III recall of its transport culture medium (Registration Certificate No.: ". The action, publicized on June 2, 2021, followed reports from Hangzhou Central Hospital and Hangzhou Dingqiao Hospital. These hospitals identified critical quality issues, specifically mold at the spiral end and black flocculent matter in the preservation solution of five virus sampling tubes. This significant product defect prompted the company's recall. The recall falls under the regulatory oversight of the National Medical Products Administration (NMPA) and the Shanghai Municipal Drug Administration. Although specific inspection dates are not detailed, the recall announcement marks the company's response to the reported quality control failures. Shanghai Kemajia Microbial Technology Co., Ltd. is required to remove the affected transport culture medium from the market, with detailed product information available in a "Medical Device Recall Event Report Form." This action highlights the company's commitment to addressing product non-conformities and ensuring medical device integrity and patient safety within the established regulatory framework.