China NMPA Product Recall - Total PSA Reagent Kit (Chemiluminescent Microparticle Immunoassay)

The National Medical Products Administration (NMPA) announced on September 18, 2021, that Abbott Ireland Diagnostics Division has initiated a voluntary Level III recall for specific models and batches of its Total PSA Reagent Kit (Chemiluminescent Microparticle Immunoassay). The recall, reported by Abbott Trading (Shanghai) Co., Ltd., stems from a packaging error where the Korean instruction manual included with the Total PSA Reagent Kit was incorrectly replaced with the manual for the Alinity Free Thyroxine Assay Kit. This issue constitutes a labeling discrepancy rather than a defect in the product's functionality or safety. Under the NMPA's regulatory guidelines, a Level III recall is typically issued for situations where the product defect is unlikely to cause adverse health consequences. Abbott Ireland Diagnostics Division's required action is the voluntary removal of the affected kits from circulation. Detailed information regarding the precise models, specifications, and batch numbers impacted by this recall is available in the accompanying Medical Device Recall Event Report Form.