China NMPA Product Recall - Automatic dehydrator

Leica Microsystems (Shanghai) Trading Co., Ltd. has initiated a voluntary Class III recall for its automated tissue dehydrator, identified under recall filing 20150549. This action, reported on June 27, 2017, and published by the National Medical Products Administration (NMPA) on July 19, 2017, addresses a discrepancy found in the product documentation and labeling.The primary issue involves an inconsistency where the voltage marked on the alarm connector located on the back of the instrument does not match the specifications provided in the Chinese instruction manual. The affected product, model/specification ASP6025, is manufactured by Leica Biosystems Nussloch GmbH and is designed for removing water from human tissues prior to pathological analysis. A total of 14 units were imported and sold in China, with specific batch numbers identified.In response to this non-conformity, Leica Microsystems (Shanghai) Trading Co., Ltd. is undertaking corrective actions. These actions include notifying all affected Chinese users about the issue and providing a service to replace or update the marking on the alarm connector to ensure alignment with the instruction manual. This voluntary recall aims to resolve the labeling inconsistency and maintain product compliance.