China NMPA Product Recall - Bond Wash Solution 10X Concentrate

Leica Biosystems Newcastle Ltd, in conjunction with Leica Microsystems (Shanghai) Trading Co., Ltd., initiated a voluntary Class III recall for its Bond Wash Solution 10X Concentrate, identified by National Medical Device Registration No. 20150492. This recall was officially reported to the National Medical Products Administration (NMPA) and publicly announced on April 23, 2023. The primary issue prompting this action was the presence of an incorrect expiration date prominently displayed on the product's label. The manufacturer recognized this labeling error as a potential risk, as it could lead to the unintended use of expired product. The regulatory framework established by the NMPA mandates strict adherence to accurate product information, including expiration dates, to safeguard public health and maintain product efficacy. While specific inspection dates are not detailed, the company's proactive voluntary recall demonstrates compliance with regulatory expectations. The required action for Leica Biosystems Newcastle Ltd involves the systematic removal of all affected batches of Bond Wash Solution 10X Concentrate from the market, ensuring that only correctly labeled and compliant products are available to users.