China NMPA Product Recall - Alanine aminotransferase assay kit (rate method)

Abbott Trading (Shanghai) Co., Ltd. initiated a voluntary Class III recall of its Alanine Aminotransferase Assay Kit (Rate Method) on June 18, 2021. The recall stems from two primary issues identified through Abbott's internal testing. Firstly, kits nearing expiration may fail to meet linearity standards, exhibiting a low recovery rate exceeding 10% for A-ALT samples above 1200 U/L. Secondly, internal interference studies revealed that bilirubin concentrations in samples greater than 31 mg/dL could alter patient results by more than 10%. Despite these findings, Abbott has not received any customer complaints or reports of adverse events globally related to these issues. The recall, overseen by the National Medical Products Administration (NMPA) and the Shanghai Municipal Drug Administration, requires Abbott to address these product deficiencies to ensure accuracy and reliability. Detailed information on affected product models and batches is available in the associated Medical Device Recall Event Report Form.