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. initiated a voluntary Level III recall on October 18, 2018, for specific batches of its Hepatitis A Virus IgG and IgM Antibody Detection Kits (Chemiluminescent Microparticle Immunoassay). This action, announced under the oversight of the National Medical Products Administration (NMPA) and the Shanghai Food and Drug Administration, addresses critical performance deviations identified in the affected products. The primary concern is that these deviations could result in falsely elevated quality control values and patient sample results, potentially compromising diagnostic accuracy. The recall involves two distinct Hepatitis A Virus IgG Antibody Detection Kits (Registration Certificate No.: 20163402553) and one Hepatitis A Virus IgM Antibody Detection Kit (Registration Certificate No.: 20163402549). Abbott Trading (Shanghai) Co., Ltd. formally reported these issues, leading to the classification of the recall as Level III, indicating that the use of or exposure to a violative product is unlikely to cause adverse health consequences. The company has detailed the affected product models, specifications, and batch numbers in an attached Medical Device Recall Event Report Form. This recall highlights the manufacturer's responsibility under regulatory frameworks to address product quality issues promptly and ensure the reliability of diagnostic tools.