China NMPA Product Recall - Human ABO blood typing reverse typing red blood cell kit; irregular antibody screening red blood cell reagent (indirect anti-human globulin method) ID-DiaCell I-II-III Asia

Bio-Rad Life Sciences (Shanghai) Co., Ltd. initiated a Class III voluntary recall of two in-vitro diagnostic products, as reported by the National Medical Products Administration (NMPA) on January 18, 2021. The affected products include the Human ABO Blood Typing Reverse Red Blood Cell Reagent Kit and the Irregular Antibody Screening Red Blood Cell Reagent (Indirect Antiglobulin Method) ID-DiaCell I-II-III Asia. The recall addresses critical performance issues identified with both reagents. For the ABO Blood Typing Reverse Red Blood Cell Reagent Kit, when used in a fully automated analyzer, insufficient homogeneity may occur if the remaining volume is 2ml or less. This can lead to a reduced red blood cell reagent concentration in testing wells, potentially increasing mismatched positive and negative results. Similarly, the Irregular Antibody Screening Reagent may exhibit nonspecific reactions, elevating the anti-screening positivity rate. Furthermore, if its volume drops below 2ml in the analyzer, reduced homogeneity and concentration could result in lower-than-expected or even false negative anti-screening results. This voluntary action, under NMPA oversight, aims to rectify these product inconsistencies and safeguard the accuracy of blood typing and antibody screening.