China NMPA Product Recall - Calibrators for biochemical analyzers; Total iron binding capacity assay kit (rate method); Iron assay dry slides (rate method)

Ausendo Medical Devices Trading (China) Co., Ltd. initiated a voluntary Class III recall of several medical diagnostic products, as reported by the National Medical Products Administration (NMPA) on March 2, 2021. The affected products include calibrators for biochemical analyzers, total iron binding capacity assay kits (rate method), and iron determination dry tablets (rate method). The company identified a potential negative shift in the performance of Total Iron Binding Capacity (TIBC) devices. This performance deviation was linked to the impact of a new MgCO3 batch comparison method, specifically affecting VITROS Iron Determination Dry Tablets (Rate Method) from GEN 26 onwards. Consequently, these products (Registration Certificate Nos.: 20172401730; 20172402238; 20152402804) were voluntarily withdrawn from the market by Ausendo to address the potential for inaccurate diagnostic results. The recall was conducted under the oversight of the NMPA, with detailed product information provided in the accompanying Medical Device Recall Event Report Form. This action demonstrates the regulatory framework's focus on ensuring the reliability and safety of medical devices.