China NMPA Product Recall - Human Immunodeficiency Virus Antigen and Antibody Combined Assay Calibrator

On February 19, 2021, the National Medical Products Administration (NMPA) published a recall notice concerning Abbott Trading (Shanghai) Co., Ltd. The company initiated a voluntary Class II recall for its Human Immunodeficiency Virus Antigen and Antibody Combined Assay Calibrator (Registration Certificate No.: 20153403721).

The primary issue identified by Abbott was an incorrect labeling of inner bottles. Specifically, some Alinity i Hepatitis A Virus IgG Antibody Calibrator inner bottles were mistakenly labeled as Human Immunodeficiency Virus Antigen and Antibody Combined Assay Calibrator. The affected batch number is 21292BE01. This mislabeling could lead to critical problems such as calibration failure, indicated by a high coefficient of variation (CV) for calibrator 1, or an invalid calibration if quality control values exceed the established upper limits, even if initial calibration appears to pass.

Abbott China confirmed that, as of the recall initiation, no complaints or adverse events had been reported related to this specific labeling error. The voluntary recall was undertaken to address these potential product quality and performance concerns, aligning with NMPA's regulatory oversight for medical devices. Further detailed information regarding the affected product models, specifications, and batches was provided in an accompanying Medical Device Recall Event Report Form.