China NMPA Product Recall - Immunohistochemical antigen retrieval buffer (Bond Epitope Retrieval Solution 2)

Leica Microsystems (Shanghai) Trading Co., Ltd. initiated a voluntary Level III recall for its immunohistochemical antigen repair buffer, Bond Epitope Retrieval Solution 2 (Registration Certificate No.: 20150327), on May 12, 2021. This action, reported through the Shanghai Municipal Drug Administration, followed the manufacturer's discovery during routine post-market surveillance. The critical issue identified was that the pH value of certain affected product batches was lower than the value specified on the product label. This deviation from quality specifications prompted the recall to maintain product integrity and ensure consistent performance in diagnostic applications. Operating within the regulatory framework established by the National Medical Products Administration (NMPA) and its local authority, the Shanghai Drug Administration, Leica Microsystems is executing this recall. The "Medical Device Recall Event Report Form" provides comprehensive details on the specific models, specifications, and batch numbers of the implicated products. The required action is a voluntary recall to retrieve all affected units. This proactive measure by the company underscores its dedication to adhering to regulatory standards and safeguarding product quality, particularly for components integral to medical diagnostic processes. The Level III classification indicates a situation where adverse health consequences from product use are unlikely but quality deviation exists.