Recall Z-2775-2016— Thermo Finnigan LLC
Class II · Terminated
Class II FDA medical device recall by Thermo Finnigan LLC, initiated 2016-07-19, terminated 2017-02-21. FDA's recall record names no specific 510(k) clearance for this event. 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.. 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
- Thermo Finnigan LLC
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2016-07-19
- Terminated
- 2017-02-21
- Firm location
- San Jose, CA, United States
Product description
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.
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.