China NMPA Product Recall - Valproic acid assay kit (immunoassay)

Aussendo Medical Device Trading (China) Co., Ltd. initiated a Class II voluntary recall of its Valproic Acid Assay Kit (Immunochemical Method) on December 26, 2018. This action, reported under the National Medical Products Administration (NMPA) framework, was prompted by a significant issue identified with the diagnostic product. The primary violation concerned a consistent negative bias in the assay results across the entire measurement range. This critical defect could lead to inaccurate valproic acid level readings, potentially impacting patient diagnosis and treatment decisions. The company, operating under a registration certificate from the Shanghai Food and Drug Administration (No.: 20162404808), took responsibility for the product's performance. A Class II recall indicates that the use of, or exposure to, the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote. Detailed information regarding the specific models, specifications, and affected batches of the kits was made available in the accompanying Medical Device Recall Event Report Form, accessible through the NMPA website. This recall underscores the importance of product accuracy and patient safety in medical diagnostics.