China NMPA Product Recall - Creatine kinase assay kit (enzyme-coupled method), creatine kinase isoenzyme assay kit (immunosuppression method)

Beckman Coulter Laboratory Systems (Suzhou) Co., Ltd. initiated a voluntary Level 3 recall for its Creatine Kinase Assay Kit (Enzyme-Conjugated Method) and Creatine Kinase Isoenzyme Assay Kit (Immunoinhibition Method). This recall, reported on June 1, 2017, and published by the National Medical Products Administration (NMPA) on July 19, 2017, addresses a labelling inaccuracy. The primary issue identified was the incorrect printing of the registration certificate number on the outer label of specific reagent kits (Registration Numbers: Su Medical Device Registration Certificate 20162401311 and 20162401310). While the company affirmed that all other product information was accurate and the defect did not impact the safety or efficacy of the product for customer use, the mislabeling constitutes a non-compliance with NMPA regulatory requirements. Under the Chinese regulatory framework for medical devices, the company was required to undertake several corrective actions. These included promptly notifying all affected customers, isolating all unsold units of the identified batches (AUZ4225 and AUZ4242), and facilitating the recall of all sold reagents to arrange for returns and exchanges. This voluntary action demonstrates the company's commitment to regulatory adherence, even for issues not directly impacting product performance.