China NMPA Product Recall - Creatine kinase isoenzyme MB assay (dry slide, rate method)

On September 28, 2021, Ausendo Medical Devices Trading (China) Co., Ltd. initiated an updated voluntary Class II recall for specific batches of its Creatine Kinase Isoenzyme MB Assay Tablets (Rate Method), identified by registration certificate no. 20152402832. This action, governed by NMPA Index No. JGXX-2021-10525 and Shanghai Drug Administration Recall No. 2021-006 (Update 1), addresses a critical product performance deficiency. The primary issue concerns product coating numbers 0245 and 0246. These batches were found to inadequately inhibit Creatine Kinase-MM (CK-MM) activity in patient samples. While the product's original instructions stipulate diluting samples with total Creatine Kinase (CK) activity exceeding 1000 U/L due to potential interference, the affected coatings demonstrated a failure to correctly inhibit CK-MM even when total CK levels were below this 1000 U/L threshold. This defect can lead to falsely elevated Creatine Kinase-MB (CK-MB) results, potentially impacting accurate patient diagnosis and treatment, as CK-MB is a vital cardiac biomarker. The company is actively managing this recall to remove affected products and uphold patient safety.