China NMPA Product Recall - Fully Automated IHC and ISH Staining System

Leica Microsystems (Shanghai) Trading Co., Ltd. initiated a voluntary Class III recall of a batch of its Fully Automated IHC and ISH Staining System. This action, reported on July 5, 2021, was undertaken due to a critical technical issue: a potential reading error in the identification of loaded reagent kits under specific operating conditions. This malfunction could compromise the accuracy and reliability of diagnostic procedures performed with the affected systems. The recall was reported through the Shanghai Municipal Drug Administration website and is overseen by the National Medical Products Administration (NMPA), the primary regulatory body in China for medical devices. The company proactively identified the defect and commenced the recall to ensure patient safety and product efficacy, adhering to the NMPA's regulatory framework for medical device post-market surveillance. Details concerning the specific product models, specifications, and affected batches are documented in the "Medical Device Recall Event Report Form," which accompanies the official notification. This recall highlights the manufacturer's responsibility to address potential safety and performance issues promptly, ensuring compliance with national medical device regulations.