Thermo Finnigan LLC recalls Endura MD Mass Spectrometer u using software versions Endura MD Software 1.0 and 1.0 SP1. In vitro diagnostic medical d…

Recall date

July 19, 2016

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2775-2016

FDA classification

Class II

Brand / firm

Thermo Finnigan LLC

Sold / distributed

Worldwide distribution - US including FL, NY and Internationally to Japan.

Why it was recalled

Thermo Fisher has determined that the Endura MD mass spectrometer instrument control software versions 1.0 and 1.0 SP! have a software defect which affect data accuracy.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Endura MD Mass Spectrometer u using software versions Endura MD Software 1.0 and 1.0 SP1. In vitro diagnostic medical device used to identify and quantify inorganic and organic compounds in the human body. Chemistry: In vitro diagnostic medical device used to identify and quantify inorganic and organic compounds in the human body.