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

Recalled September 21, 2016 · FDA recall Z-2775-2016 · Thermo Finnigan

Hazard

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. · FDA Class II

Units

6 (5 in Us distribuion and 1 in Japan)

Sold at

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

Description

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.

Product

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.

Manufacturer(s)

Thermo Finnigan LLC

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →