China NMPA Product Recall - Hepatitis A Virus IgG Antibody Detection Kit (Chemiluminescent Microparticle Immunoassay), Hepatitis A Virus IgM Antibody Detection Kit (Chemiluminescent Microparticle Immunoassay)

Abbott Trading (Shanghai) Co., Ltd., also referred to as Abbott Laboratories Limited, initiated a voluntary recall in December 2018, as reported by the Shanghai Food and Drug Administration under the National Medical Products Administration (NMPA) framework. The recall was prompted by identified performance deviations in specific batches of Hepatitis A Virus IgG Antibody Test Kits (chemiluminescent microparticle immunoassay). These deviations had the potential to cause falsely elevated quality control values and inaccurate patient sample results. Consequently, Abbott voluntarily recalled two types of Hepatitis A Virus IgG Antibody Detection Kits and two types of Hepatitis A Virus IgM Antibody Detection Kits. This action was classified as a Level III recall, indicating that the use of, or exposure to, the affected products is unlikely to cause adverse health consequences. Detailed information on the specific models, specifications, and batches was provided in a "Medical Device Recall Event Report Form," demonstrating the company's commitment to product integrity and patient safety.