China NMPA Product Recall - ABO forward and reverse typing and RhD blood typing reagent cards (column agglutination method); ABO/Rh blood typing retest cards (column agglutination method)

On October 30, 2020, Ortho BioVue Medical Devices Trading (China) Co., Ltd. initiated a voluntary Class III recall of specific ABO Forward and Reverse Typing and RhD Blood Typing Reagent Cards, along with ABO/Rh Blood Typing Retest Cards. This action was reported through the National Medical Products Administration (NMPA). The core issue identified involved the presence of a small quantity of agglutinants within the anti-A and anti-AB microcolumns of the affected Ortho BioVue series blood typing diagnostic reagent cards. When these particular cards are processed using the Ortho AutoVue image processing system, these internal agglutinations risk being misinterpreted as mixed-field (MF) reactions. Such misinterpretations could potentially lead to inaccurate blood typing results, which carries a significant risk to patient safety. The recall pertains to products with Registration Certificate Nos. 20163404540 and 20173400488. Ortho BioVue Medical Devices Trading (China) Co., Ltd. is responsible for implementing this recall to rectify the product non-conformity and uphold the reliability of their diagnostic products. Customers impacted by this recall are advised to consult the "Medical Device Recall Event Report Form" for comprehensive details regarding the specific models, specifications, and batch numbers involved.