China NMPA Product Recall - Benchtop Incubator

William A. Cook Australia, Pty. Ltd. has initiated a voluntary Class III recall for its Benchtop Incubator, identified under Registration Certificate No.: 20162185127. This regulatory action, published by Cook (China) Medical Trading Co., Ltd., stems from a significant translation error discovered in the Italian and Swedish versions of the product's instructions for use. The identified inaccuracy pertains to a specific model and batch of the incubator, with comprehensive details provided in the accompanying "Medical Device Recall Event Report Form." The National Medical Products Administration (NMPA) is the overseeing regulatory authority for this recall. The classification as a Class III recall indicates that while the issue is serious enough to warrant a recall, the likelihood of adverse health consequences from product use is considered remote. However, precise and accurate instructions are paramount for medical devices to ensure correct operation, patient safety, and effective clinical use. This voluntary recall highlights the manufacturer's diligence in upholding product integrity and complying with international standards for medical device labeling. The company's action ensures that all users possess accurate guidance, preventing potential misuse or misunderstanding that could arise from incorrect translated information. Further specifics about the affected product models and batch numbers are accessible via NMPA's official documentation.