China NMPA Product Recall - Anti-human globulin (IgG) test card (column agglutination method); Anti-human globulin (IgG, C3b/C3d) test card; ABO forward and reverse typing and RhD blood typing reagent cards (column agglutination method)

Ortho-Clinical Diagnostics (UK) Ltd., in conjunction with Ortho Medical Devices Trading (China) Co., Ltd., initiated a voluntary Class III recall of specific medical devices announced on April 10, 2020. The recall, overseen by China's National Medical Products Administration (NMPA) and publicized by the Shanghai Municipal Drug Administration, addresses a manufacturing anomaly. The primary issue involves an elevated rate of air bubbles within the ORTHO BioVue System Cassettes in affected batches. This defect impacts critical diagnostic products, including Anti-human globulin (IgG) test cards, Anti-human globulin (IgG, C3b/C3d) test cards, and ABO forward and reverse typing and RhD blood typing reagent cards. The required action involves Ortho-Clinical Diagnostics (UK) Ltd. voluntarily removing these identified products from the market. Further detailed information regarding affected models, specifications, and batch numbers was made available in the