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

Aussendo Medical Devices Trading (China) Co., Ltd. initiated a voluntary Class II recall for its Creatine Kinase Isoenzyme MB Assay Dry Tablets (Rate Method), announced by the National Medical Products Administration (NMPA) on January 6, 2021. The recall stems from a significant performance issue where the diagnostic strips can produce falsely elevated Creatine Kinase-MB (CK-MB) results. The product's instructions indicated a limitation where total CK activity exceeding 1000 U/L might lead to elevated CK-MB, suggesting dilution for such samples. However, subsequent findings revealed that the strips' coating inadequately inhibits CK-MM when total CK is above 1000 U/L. More critically, samples with total CK *below* 1000 U/L may also exhibit these inaccurate, falsely high CK-MB readings, indicating a broader unreliability than initially documented. This defect poses a risk of misdiagnosis or inappropriate patient management due to erroneous cardiac biomarker results. Ausendo is undertaking this recall to address the product's inability to reliably provide accurate measurements. Specific affected product models, specifications, and batch numbers are detailed in the accompanying Medical Device Recall Event Report Form.