China NMPA Product Recall - Vizion Microbial Antimicrobial Susceptibility Analyzer

Thermo Fisher Scientific (China) Co., Ltd. initiated a voluntary Class III recall of its "Vizion Microbial Antimicrobial Susceptibility Analyzers," as reported by the National Medical Products Administration (NMPA) and the Shanghai Municipal Drug Administration on March 30, 2021. The primary issue identified was an incorrect Chinese registration certificate number displayed on certain units of the device (Registration Certificate No.: 国械注进20182401764). The company's internal assessment concluded that this labeling discrepancy did not compromise the accuracy of test results, the time required to obtain them, or pose any clinical risk to patients. Despite the absence of clinical risk, Thermo Fisher Scientific proactively decided to proceed with the recall to address the administrative inaccuracy. The action was taken under the oversight of China's regulatory bodies, the NMPA, which is responsible for the supervision of medical devices. Detailed information concerning specific models, specifications, and affected batches is available in the accompanying "Medical Device Recall Event Report Form," underscoring the company's commitment to regulatory compliance and product integrity.