China NMPA Product Recall - Creatine kinase (CK) assay kit (N-acetylcysteine method)

Zhongshan Chuangyi Biochemical Engineering Co., Ltd. has initiated a voluntary Class III recall of its Creatine Kinase (CK) Assay Kit (N-Acetylcysteine Method). This action was publicly reported on July 2, 2021, and originated from information published by the Guangdong Provincial Drug Administration website, overseen by the National Medical Products Administration (NMPA). The recall specifically pertains to certain product specifications and batches, with detailed information available in the company's "Medical Device Recall Event Report Form." While the document confirms the recall's voluntary nature and its classification, it does not specify the exact reasons for the recall or provide details regarding inspection dates or specific violations that prompted the action. The company is responsible for implementing the recall of the affected medical devices to ensure product safety and compliance with regulatory standards.