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

Leica Microsystems (Shanghai) Trading Co., Ltd. initiated a voluntary Class III recall for specific batches of its Fully Automated IHC and ISH Staining System. This action, reported on July 5, 2021, was prompted by a critical issue: a potential reading error in identifying loaded reagent kits under certain operating conditions. This malfunction could lead to inaccurate assay results, potentially affecting diagnostic outcomes. The National Medical Products Administration (NMPA) oversees this recall, with further details on affected models, specifications, and batches provided in the accompanying "Medical Device Recall Event Report Form" issued by the Shanghai Municipal Drug Administration. While specific inspection dates are not detailed in this public notice, the company's report indicates compliance with NMPA's regulatory framework for addressing product non-conformities. The required action for Leica Microsystems (Shanghai) Trading Co., Ltd. is to effectively manage this recall, ensuring all impacted systems are retrieved or remediated in accordance with regulatory guidelines to safeguard patient safety from the identified reading error.