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 for its immunohistochemical antigen repair buffer, specifically the Bond Epitope Retrieval Solution 1. This action, reported on June 8, 2021, by the National Medical Products Administration (NMPA) and the Shanghai Municipal Drug Administration, stemmed from critical issues identified during the manufacturer's post-market monitoring activities. The primary violation involved the pH value of affected product batches, which was found to be lower than the value indicated on the product label. Such a deviation is significant for the intended performance of medical devices used in diagnostic procedures. Under the regulatory framework overseeing medical products, the company is required to provide comprehensive details, including specific models, specifications, and batch numbers of all affected products, as outlined in the