China NMPA Product Recall - Biological microscope

Carl Zeiss (Shanghai) Management Co., Ltd. proactively announced a voluntary Level III recall for specific biological microscope models, Axio Observer 3 and Axio Imager Z2. This recall, published on June 17, 2021, was initiated after an internal investigation identified a critical labeling error. During the shipping process to China, operators inadvertently confused the Chinese language labels on these two distinct medical devices. This labeling mix-up created a potential risk of customer confusion, impacting accurate product identification and potentially misapplication by end-users. The company

s decision to recall these devices demonstrates its commitment to product integrity and user safety, operating under the regulatory guidance of the National Medical Products Administration (NMPA) and the Shanghai Municipal Drug Administration. As a required action, Carl Zeiss (Shanghai) Management Co., Ltd. is retrieving all affected units, identified by registration certificate numbers 国械注进20172226736 and 国械注进20172226806. Detailed information regarding the scope of the recall, including specific models, specifications, and batch numbers, is accessible through the Medical Device Recall Event Report Form. This incident highlights the critical importance of stringent quality control in labeling and packaging medical devices to prevent operational discrepancies and ensure consumer confidence.