China NMPA Product Recall - Biological microscope

Zeiss Technology (Suzhou) Co., Ltd. has initiated a voluntary Level III recall for 38 units of its biological microscopes, specifically models Axioscope 5 TL and Axioscope 5-TL, sold within China. This action, reported to the National Medical Products Administration (NMPA) and published on December 15, 2021, addresses a labeling discrepancy rather than a safety defect. The main issue identified is an incorrect product model number printed on the Chinese labels affixed to the microscopes. The company emphasizes that this error does not impact the safety or functional performance of the equipment, which is designed for use by authorized medical professionals in analyzing various biological samples, including cells, tissues, blood, and pathological slides. Given the Level III classification, the NMPA assesses that the use of these products is not likely to cause adverse health consequences. For required actions, Zeiss Technology (Suzhou) Co., Ltd. is facilitating direct contact with affected users to inform them about the corrective measures in place to rectify the labeling inaccuracy. This proactive recall ensures adherence to regulatory standards for product information in the Chinese market.