Endura MR Mass Spectrometer Cl II

Company: Thermo Finnigan LLC.
Date of Enforcement Report 9/21/2016
Class lI:

PRODUCT

Endura MR 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.
Recall Number Z-2775-2016

REASON
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.

RECALLING FIRM/MANUFACTURER
Thermo Finnigan LLC, San Jose, CA on 9/9/2016. Voluntary: Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
6

DISTRIBUTION
US including FL, NY and Internationally to Japan.

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