FDAnews Device Daily Bulletin

FDA Cautions Lab Staff on Mass Spectrometers

Sept. 8, 2016

The FDA is alerting lab staff and healthcare professionals about a software defect in Sciex mass spectrometers. The defect may cause the devices to incorrectly assign results to samples analyzed.

Sciex notified the FDA that, under certain conditions, the defect in the Analyst Software Versions 1.6.1 and 1.6.2, and MultiQuant Software Versions 3.0, 3.0.1, and 3.0.2. may lead the devices to display results that do not match the specimens tested. — Tamra Sami

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