Medical Device Safety and Recalls: FDA Safety Communication: Incorrect Assignment of Test Results Associated with Sciex Mass Spectrometers

Today, the U.S. Food and Drug Administration issued a Safety Communication: “Incorrect Assignment of Test Results Associated with Sciex Mass Spectrometers.” The FDA is alerting lab staff and health care professionals about a software defect in Sciex mass spectrometers. This software defect may cause the devices to incorrectly assign results to samples analyzed.

The FDA Safety Communication is available on the FDA website: http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm518830.htm

Food and Drug Administration
Center for Devices and Radiological Health