China NMPA Product Recall - Hepatitis A virus IgG antibody detection kit, Hepatitis A virus IgM antibody detection kit

Abbott Trading (Shanghai) Co., Ltd. initiated a voluntary Class III recall of its Hepatitis A Virus IgG Antibody Detection Kits and Hepatitis A Virus IgM Antibody Detection Kits, as announced on October 29, 2018. This action, overseen by the National Medical Products Administration (NMPA) and the Shanghai Food and Drug Administration, addresses significant performance deviations. Specifically, certain batches of the Hepatitis A Virus IgG Antibody Detection Kits were found to produce falsely elevated quality control values and patient sample results. Such inaccuracies could lead to misdiagnoses of Hepatitis A infection, posing a risk to patient health and treatment decisions. The recall applies to kits with registration certificate numbers 20163402553 and 20163402549. Abbott Trading (Shanghai) Co., Ltd. is responsible for executing the recall, with comprehensive details on affected product models, specifications, and batches provided in the associated Medical Device Recall Event Report Form. This measure emphasizes the company's adherence to product safety standards and regulatory compliance within the medical device sector.