Ortho Clinical Diagnostics Inc, CL2022-209, ORTHO Optix Reader ORTHO BioVue Cassettes

On the ORTHO Optix Reader, when reviewing the results, the user can edit a grade and/or analysis of the results. When performing this action, the user may also choose to cancel the edit. While cancelling the edit, the user is incorrectly informed that the ‘Changes have not been saved’ via a user interface prompt, which the user must acknowledge/accept. After the user accepts cancel of the edit, the result displayed on the user interface reverts to the original result and awaits result approval, as expected. When the user completes result approval (displayed with the original result), the result that is actually stored in the database and reported out of the system (such as to a connected LIS) is the edited result that the user thinks was previously cancelled.