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 Class III recall for specific batches of its Creatine Kinase Assay Kits (Enzyme-Conjugated Method) and Creatine Kinase Isoenzyme Assay Kits (Immunoinhibition Method). The recall, reported on June 1, 2017, and published on June 5, 2017, stems from a labeling inaccuracy: the registration certificate number was incorrectly printed on the outer label of the reagent kits. While the company confirmed that this error does not impact product efficacy or customer use, it represents a non-conformance with established regulatory requirements governing medical device labeling in China. The affected product batches include AUZ4225 and AUZ4242, with various specifications. In response, Beckman Coulter Laboratory Systems (Suzhou) Co., Ltd. is undertaking several corrective actions. These include promptly notifying all customers who received the affected products, isolating any unsold reagents from the specified batches, and facilitating the recall of all sold reagents, offering returns and exchanges as appropriate. This action ensures adherence to the regulatory standards set by the medical device registration authority in Jiangsu, China, concerning product identification and documentation.