China NMPA Product Recall - Human ABO blood typing reverse typing uses a 0.8% erythrocyte reagent kit (column agglutination method); human ABO blood typing reverse typing uses a 3% erythrocyte reagent kit (column agglutination method); human irregular antibody detection uses a 3% erythrocyte reagent kit (column agglutination method).

Ausendo Medical Devices Trading (China) Co., Ltd., on behalf of manufacturer Ortho-Clinical Diagnostics, initiated a voluntary Class II recall for specific batches of its 0.8% and 3% Red Blood Cell Reagent Kits for Human ABO Blood Typing and 3% Red Blood Cell Reagent Kit for Human Irregular Antibody Detection (Column Agglutination Method). This recall was reported on November 22, 2016, and published by the National Medical Products Administration (NMPA) on December 29, 2016. The core issue identified was microbial contamination of certain raw materials, which could lead to significant hemolysis in the red blood cell reagent products. If used in testing, these affected reagents had the potential to generate incorrect results, including false positives or false negatives, thereby posing a risk of harm to patients. Although the recall was initiated globally, a diagnostic investigation revealed that products marketed and sold within China did not exhibit hemolysis during customer acceptance or use. Furthermore, the company received no complaints regarding hemolysis for products distributed in China, and relevant batches had largely been consumed. Consequently, Ausendo Medical Devices Trading (China) Co., Ltd. reported the event to the Shanghai Food and Drug Administration but took no further on-site actions in China. The company did not submit subsequent recall implementation reports, investigation reports, or summary reports for the China market, as the significant hemolysis incident did not affect products sold domestically.