China NMPA Product Recall - High-Sensitive Troponin-I Reagent Kit (Chemiluminescent Microparticle Immunoassay)

The National Medical Products Administration (NMPA) has announced a voluntary Class III recall initiated by Abbott Ireland Diagnostics Division, reported by Abbott Trading (Shanghai) Co., Ltd. The recall, published on August 10, 2022, pertains to their STAT High Sensitive Troponin-I Reagent Kit (Chemiluminescent Microparticle Immunoassay). The core issue identified is an insufficient amount of heterophile antibody blocking agent in the conjugate of specific product models and batches. This deficiency presents a critical risk: it may lead to falsely low test results in patients positive for heterophile antibodies (HAMA) or other interfering factors (FA). Such inaccurate readings could potentially compromise clinical diagnoses related to cardiac conditions. As a required action, Abbott Ireland Diagnostics Division is voluntarily recalling the affected kits (Registration Certificate No.: 20172400287). Detailed information, including specific product models, specifications, and batch numbers, is provided in the "Medical Device Recall Event Report Form" to ensure the identification and removal of all impacted products under the NMPA's regulatory oversight.