China NMPA Product Recall - Fully automated blood typing analyzer

Ortho Medical Devices Trading (China) Co., Ltd. has initiated a voluntary Class III recall for its fully automated blood typing analyzers, including Ortho VISION and Ortho VISION Max models. This action, reported by the National Medical Products Administration (NMPA) on June 30, 2021, addresses a critical safety concern. The main issue arises when an operator presses the cancel button during maintenance mode, which can lead to unexpected and uncontrolled movement of the device's gripper and pipette arms. This unexpected motion poses potential safety risks or could compromise the integrity of the analysis. Operating within the regulatory framework of the NMPA, the company is proactively recalling the affected devices to mitigate this hazard. A Class III classification suggests that while the issue is concerning, it is unlikely to cause severe adverse health consequences. Detailed information regarding specific affected product models, specifications, and batch numbers is available in the accompanying Medical Device Recall Event Report Form, outlining the company's required actions to ensure product safety and compliance.