China NMPA Product Recall - Immunohistochemical Antigen Retrieval Buffer (Bond Epitope Retrieval Solution 1)

Leica Microsystems (Shanghai) Trading Co., Ltd. initiated a voluntary Class III recall on May 12, 2021, for its immunohistochemical antigen repair buffer, specifically the Bond Epitope Retrieval Solution 1 (Registration Certificate No.: 20150328). This action, reported by the Shanghai Drug Administration, was prompted by post-market monitoring findings by the manufacturer. It was discovered that the pH value of certain affected product batches was lower than the stated pH value on the product label. This deviation could potentially impact the product's performance and efficacy in its intended diagnostic application.

The recall was undertaken in cooperation with the National Medical Products Administration (NMPA) and the Shanghai Municipal Drug Administration, ensuring adherence to national medical device regulatory frameworks. As a Class III recall, it indicates that the use of or exposure to a violative product is not likely to cause adverse health consequences, but the company proactively addressed the identified quality control issue. Detailed information on specific models, specifications, and affected batches was provided in an accompanying Medical Device Recall Event Report Form, signifying the company's commitment to product safety and regulatory compliance.