China NMPA Product Recall - Bond Wash Solution 10X Concentrate

On May 12, 2021, the National Medical Products Administration (NMPA) published details concerning a voluntary Class III recall initiated by Leica Microsystems (Shanghai) Trading Co., Ltd. The recall specifically targets their Bond Wash Solution 10X Concentrate, identified by Registration Certificate No.: 国械备20150492. The pivotal issue leading to this action was uncovered during the manufacturer's post-market monitoring activities. It was determined that certain affected batches of the cleaning solution displayed a pH value that was lower than what was specified on the product's label. This deviation from the labeled specifications necessitated corrective action. Under the regulatory framework governed by the NMPA, with information reported through the Shanghai Municipal Drug Administration, Leica Microsystems (Shanghai) Trading Co., Ltd. implemented the required action of a voluntary recall. A Class III recall indicates that the use of or exposure to the affected product is unlikely to cause adverse health consequences. Stakeholders requiring further specifics on the implicated product models, specifications, and batch numbers are directed to consult the comprehensive “Medical Device Recall Event Report Form” attached to the official communication.