China NMPA Product Recall - Human ABO blood typing reverse typing kit (0.8% red blood cell kit), human ABO blood typing reverse typing kit (3% red blood cell kit), human irregular antibody detection kit (3% red blood cell kit).

Ortho-Clinical Diagnostics Medical Device Trading (China) Co., Ltd. initiated a voluntary Class II recall, reported to the National Medical Products Administration (NMPA) on December 12, 2016, and published on January 13, 2017. The recall pertains to specific batches of its 0.8% and 3% Red Blood Cell Reagent Kits for Human ABO Blood Typing Reverse Determination, and the 3% Red Blood Cell Reagent Kit for Human Irregular Antibody Detection. The primary issue is microbial contamination within certain raw materials, which could cause significant hemolysis in affected reagent products. This contamination carries the risk of generating false positive or false negative diagnostic results, potentially jeopardizing patient safety. The impacted products are identifiable by expiry dates before January 24, 2017, and were imported into China under NMPA registration. As part of the corrective measures, Ortho-Clinical Diagnostics instructed customers to visually inspect all products before daily use and to discontinue use of any showing significant hemolysis or visible contamination. Customers were advised to contact Ortho staff to report affected products for replacement or return. The company also implemented internal incoming inspections at its warehouse to identify and report any hemolyzed products. This proactive recall demonstrates adherence to NMPA regulatory frameworks for medical device safety.