China NMPA Product Recall - Biochemical general quality control products

On November 3, 2020, Ausendo Medical Devices Trading (China) Co., Ltd. initiated a voluntary Class III recall of its biochemical general quality control products. The recall stems from a identified issue with unopened biochemical general quality control product II, specifically batch Q7692, which demonstrated a potential negative bias in the Alkaline Phosphatase (ALKP) value when stored under refrigeration. This deviation could impact the accuracy of diagnostic results, thus presenting a potential risk to patient care. The company's action falls under the regulatory authority of the National Medical Products Administration (NMPA) and the Shanghai Municipal Drug Administration. The affected product carries Registration Certificate No.: 国械注进20172400282. A Class III recall indicates that exposure to the product is unlikely to cause serious adverse health consequences, but the company is taking this measure to uphold the reliability and accuracy of its diagnostic tools. Affected parties were advised to consult the "Medical Device Recall Event Report Form" for comprehensive details regarding the specific models, specifications, and batches involved in this recall. This voluntary measure highlights the manufacturer's dedication to product quality and patient safety.