China NMPA Product Recall - Hepatitis B Virus Surface Antigen Quantitative Assay Kit (Chemiluminescent Microparticle Immunoassay)

On June 17, 2020, Abbott Trading (Shanghai) Co., Ltd. initiated a voluntary Class III recall for its "Hepatitis B Virus Surface Antigen Quantitative Assay Kit (Chemiluminescent Microparticle Immunoassay)". This action, overseen by the National Medical Products Administration (NMPA), was prompted by a labeling inaccuracy in the product's Chinese version. The primary issue involved a change in the product's official name. Previously, the Chinese label included the word "quantitative," but regulatory updates required its removal, thus simplifying the name to "Hepatitis B Virus Surface Antigen Assay Kit." This discrepancy between the old and new labels necessitated the recall to ensure compliance with NMPA standards. Abbott Trading (Shanghai) Co., Ltd. is addressing this labeling inconsistency through the recall of specific affected product models, specifications, and batches, detailed in an accompanying recall report form. This demonstrates the company's commitment to maintaining accurate product information and adhering to regulatory requirements under the NMPA framework.