China NMPA Product Recall - Automatic dehydrator

Leica Microsystems (Shanghai) Trading Co., Ltd. initiated a voluntary Class III recall of its Automated Tissue Dehydrator, model ASP6025, as reported to the National Medical Products Administration (NMPA) on June 27, 2017, with public notification on July 18, 2017. The recall, impacting 14 units imported into China, addresses a critical labeling inconsistency. Specifically, the voltage marked on the alarm connector located on the back of the instrument was found to be inconsistent with the specifications detailed in the Chinese instruction manual. Manufactured by Leica Biosystems Nussloch GmbH, this device is used for tissue preparation in pathological analysis. To resolve this, Leica Microsystems (Shanghai) Trading Co., Ltd. is contacting all affected Chinese users to implement a corrective action: physically replacing or updating the incorrect voltage marking on the alarm connector of the affected devices. This action ensures consistency with the official instruction manual and maintains product compliance.