China NMPA Product Recall - Human ABO blood typing reverse typing uses a 0.8% red blood cell kit; human ABO blood typing reverse typing uses a 3% red blood cell kit; human irregular antibody detection uses a 3% red blood cell kit.

Ausendo Medical Devices Trading (China) Co., Ltd. initiated a voluntary Class II recall of several critical diagnostic products, as reported by the National Medical Products Administration (NMPA) on January 13, 2017. The affected products include the 0.8% Red Blood Cell Reagent Kit for Human ABO Blood Typing Reverse Determination, the 3% Red Blood Cell Reagent Kit for Human ABO Blood Typing Reverse Determination, and the 3% Red Blood Cell Reagent Kit for Human Irregular Antibody Detection. The primary issue prompting this recall was the discovery of microbial contamination within certain raw materials used in the manufacturing process. This contamination presents a significant risk, as it may cause substantial hemolysis in red blood cell products and other products containing red blood cells. Such an issue could compromise the accuracy and reliability of crucial blood typing and antibody detection tests, potentially leading to incorrect diagnoses or treatment decisions. Under the oversight of the NMPA, Ausendo Medical Devices Trading (China) Co., Ltd. has taken the necessary step to recall the impacted batches to mitigate potential patient risks. While no specific inspection dates were provided, the company’s action reflects its responsibility to address quality concerns identified internally. The Class II designation indicates that the product defect could cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote. The company is required to remove all identified affected products from the market to ensure public health and safety.