FDA-Device2016-09-21Class II
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.
Thermo Finnigan LLC
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.
Sold states
Worldwide distribution - US including FL, NY and Internationally to Japan.
Affected count
6 (5 in Us distribuion and 1 in Japan)
Manufactured in
355 River Oaks Pkwy, N/A, San Jose, CA, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2775-2016Don't want to check this manually?
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