China NMPA Product Recall - Irregular Antibody Screening Red Blood Cell Kit / Human ABO Blood Typing Reverse Type Kit

The National Medical Products Administration (NMPA) has publicized a voluntary Class III recall initiated by Bio-Rad Life Sciences (Shanghai) Co., Ltd. This action addresses quality control issues identified with their "Irregular Antibody Screening Red Blood Cell Reagent Kit" and, by extension, the "Human ABO Blood Typing Reverse Type Kit". Bio-Rad Life Sciences (Shanghai) Co., Ltd. reported discovering unexpected reactions when the "Irregular Antibody Screening Red Blood Cell Reagent Kit" was used in conjunction with eluent and quality control (QC) samples. This self-identified issue prompted the company's decision to recall the affected products, acknowledging a deviation from expected performance. Operating under the regulatory framework of the NMPA, Bio-Rad Life Sciences is undertaking corrective measures. While specific NMPA inspection dates are not detailed within this publication, the recall document was published on May 8, 2017. Comprehensive information regarding the specific product models, specifications, and batch numbers for the recalled items is available in the associated "Medical Device Recall Event Report Form". This recall underscores the critical importance of robust internal quality assurance processes to maintain product reliability and ensure patient safety within the medical device sector.