From the standpoint of the patient, an IVD examination result would be considered a hazard if it could lead to (1) inappropriate medical intervention that can result in harm, or-(2) lack of medical intervention necessary to prevent being harmed. The following general hazards could cause or contribute to potentially harmful medical decisions. The specific hazards should be identified in terms of the magnitude and direction of error, the extent of delay, or the ancillary information that is incorrect or missing.