Aug. 19, 2025
Important safety information
Alinity s system intended use and important safety information
Intended Use: The Alinity s System is intended for In Vitro diagnostic use only. The Alinity s System is a high‐throughput, fully‐automated immunoassay analyzer designed to determine the presence of specific antigens and antibodies by using chemiluminescent immunoassay technology. The system is intended to perform high throughput routine and priority processing while allowing continuous access and automated retesting. The Alinity s System is intended to produce donor specific and other routine specimen results based on the available menu. It is intended to be used in donor screening, plasma and plasmapheresis screening, and organ donor centers, hospitals, and reference laboratories.
Important Usage and Safety Information: Use the system only according to its designed purpose. Operators must be trained before operating the system. Failure to comply with safe‐use instructions may cause personal injury, harm the environment, damage the system, or adversely affect test results.
Refer to the operations manual or user guide for Warnings, Precautions and Limitations for proper use of the instrument: www.transfusion.abbott/PI.
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