China NMPA Product Recall - Anaerobic microbial culture medium

On April 29, 2019, Thermo Fisher Scientific (China) Co., Ltd. initiated a voluntary Level III recall for a specific batch (No.: 411253) of its Anaerobic Microbial Culture Media. The primary issue prompting this action was the discovery of incorrectly printed Chinese label information on the product. While not indicating a functional defect, inaccurate labeling represents a serious regulatory violation, as precise product identification, usage instructions, and safety information are crucial for proper application in clinical and laboratory environments. This recall falls under the regulatory framework of the National Medical Products Administration (NMPA) and pertains to products registered under certificate number 20152402951. A Level III recall signifies that the product's use is unlikely to cause adverse health consequences, but corrective action is essential for compliance. Thermo Fisher Scientific (China) Co., Ltd. fulfilled its required actions by reporting the discrepancy to the NMPA and initiating the recall, making a "Medical Device Recall Event Report Form" available for detailed information on affected products. This incident highlights the critical importance of stringent adherence to labeling standards enforced by Chinese regulatory authorities to maintain product integrity and user safety.