China NMPA Product Recall - Creatine kinase isoenzyme (CK-MB) assay kit (enzyme-mediated immunosuppression method)

Beckman Coulter Trading (China) Co., Ltd. initiated a voluntary Class III recall for its Creatine Kinase Isoenzyme (CK-MB) Detection Kit (Enzyme Immunoinhibition Method), catalog number OSR61155. This action, published on May 14, 2021, follows internal interference testing that revealed the product failed to meet the specified lipemia interference statement in its Instructions for Use. The core issue was that the kit did not maintain intralipid interference below 20% when lipemia was under 900 mg/dL, contrary to its stated performance. The company anticipates that all batches of the CK-MB kit will exhibit similar interference problems. While this deviation affects the product's performance specifications, Beckman Coulter assessed the risk to patient safety from potentially delayed or inaccurate results as "very low." The recall is being conducted under the oversight of the National Medical Products Administration (NMPA) and the Shanghai Municipal Drug Administration, adhering to established medical device regulatory frameworks in China. As a required action, the company is voluntarily recalling all affected creatine kinase isoenzyme assay kits, with specific details on models, specifications, and batches made available in an accompanying Medical Device Recall Event Report Form.