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

Ausendo Medical Devices Trading (China) Co., Ltd. initiated a voluntary Class III recall on July 2, 2019, for several of its medical devices. The affected products include Anti-Human Globulin (IgG) Test Cards, ABO/Rh Blood Typing Cards, ABO Forward and Reverse Typing and RhD Blood Typing Reagent Cards, and Anti-Human Globulin (IgG, C3b/C3d) Test Cards. This action was prompted by an issue where labels on certain system test cards were not adequately adhered, leading to a risk of the labels peeling. If a label detaches significantly, it could cause the test card to become jammed within testing instruments. The recall was reported to the Shanghai Food and Drug Administration and falls under the oversight of the National Medical Products Administration (NMPA). Specific models, specifications, and batch details are available in the recall event report form. This voluntary recall addresses a potential functional defect that could impact the reliability of diagnostic testing.