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Medical Devices / Postmarket Safety

FDA Recalls Sciex Mass Spectrometers for Incorrect Test Results

Sept. 6, 2016

Sciex has issued a voluntary recall for mass spectrometers for clinical use due to the defect in the software that may lead the devices to display results that do not match the specimens tested.

Mass spectrometers are used in lab settings to identify inorganic or organic compounds in human specimens. The devices separate isotopes, molecules, and molecular fragments according to their mass through electric and magnetic fields.

The recall covers Sciex API 3200tm LC/MS/MS System, 3200md Qtrap LC/MS/MS System, Triple Quadtm 4500 LC/MS/MS System, and the Qtrap 4500 LC/MS/MS equipped with the analyst software versions 1.6.1 and 1.6.2, and the Multiquant software versions 3.0, 3.0.1, and 3.0.2. — Cynthia Jessup

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