China NMPA Product Recall - Antimicrobial susceptibility inoculation culture medium

The National Medical Products Administration (NMPA) has released information concerning a voluntary Class III recall initiated by Remel, Inc. for its antimicrobial susceptibility testing inoculation culture medium. Reported by Thermo Fisher Scientific (China) Co., Ltd., the recall addresses a critical product issue: an atypical dark color observed in affected batches. This color deviation can severely impact diagnostic processes, potentially causing antimicrobial susceptibility testing plates to be unreadable by automated systems, or leading to minimum inhibitory concentration (MIC) results that exceed their expected target values. Remel, Inc. is executing this voluntary recall for the product, which is registered under National Medical Device Registration No. 20140220. Importantly, the specific models and batches of products involved in this recall were not imported into China. Comprehensive details regarding the affected products, including specific models and specifications, are documented in the "Medical Device Recall Event Report Form" provided by Remel Company.