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 was reported on June 1, 2017, and officially published by the National Medical Products Administration (NMPA) on July 18, 2017.

The main issue leading to the recall was an incorrectly printed registration certificate number on the outer label of specific reagent kits. Affected batches included AUZ4225 for product OSR6279 and AUZ4242 for product OSR61155. While the company confirmed that this labeling discrepancy did not impact the product's functionality or customer use, it represented a non-compliance with NMPA's regulatory requirements, thus necessitating the recall.

As part of the corrective actions, Beckman Coulter was mandated to notify all affected customers, ensure the isolation of any unsold reagents from the identified batches, and manage the recall of all sold reagents, providing options for returns and exchanges. This action underscores the necessity of accurate labeling and strict adherence to regulatory standards, even for issues that do not directly compromise product efficacy.