China NMPA Product Recall - Alinity's System Fully Automated Chemiluminescence Immunoassay Analyzer

Abbott Trading (Shanghai) Co., Ltd. initiated a voluntary Class III recall on August 12, 2021, for its Alinitys System Fully Automated Chemiluminescence Immunoassay Analyzer. This action, reported to the National Medical Products Administration (NMPA), addresses a critical issue with the instrument's waste liquid pressure monitoring system. The core problem stems from a faulty pressure sensor that prevents the system from detecting pressure buildup in the external waste tubing, which can occur if the tubing is blocked or an air inlet valve is inadvertently closed. Due to this malfunction, the Alinitys system fails to cease processing new test requests or generate a "high waste pressure detected" alert (information code 5101). This oversight means the system continues to operate without warning of a potentially hazardous pressure buildup, which could lead to operational inefficiencies or safety concerns within a laboratory setting. Abbott Trading (Shanghai) Co., Ltd. has taken proactive steps to recall the affected Alinity s System, specifically those under Registration Certificate No.: 20193400001. Detailed information regarding specific models, specifications, and batch numbers is available in the accompanying "Medical Device Recall Event Report Form." This voluntary recall underscores the company's commitment to product safety and compliance under NMPA oversight.