China NMPA Product Recall - Human Irregular Antibody Detection Kit (3% Red Blood Cell Reagent Method)

On April 23, 2020, Ortho-Clinical Diagnostics (UK) Limited initiated a voluntary Class III recall of its 3% Red Blood Cell Reagent Kit for Human Irregular Antibody Detection (Column Agglutination Method). This action, overseen by the National Medical Products Administration (NMPA), was prompted by a critical information omission in the product's ANTIGRAM antigen profile. The main issue identified was that single-cell HLA class I antigen positivity was not explicitly listed in the "Special Antigen Typing" column. This omission could potentially affect the accurate interpretation and detection of irregular antibodies in clinical diagnostics. To address this labeling deficiency and maintain product integrity, Ortho-Clinical Diagnostics proactively recalled the affected product batches. Detailed information regarding specific models, specifications, and batch numbers was provided in an accompanying Medical Device Recall Event Report Form, ensuring transparency in this regulatory action.