Reported Sep 21, 2016 · Terminated
Endura MD Mass Spectrometer u using software versions Endura MD Software 1.0 and 1.0 SP1. In vitro diagnostic medical…
Thermo Finnigan LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Thermo Finnigan LLC · 355 River Oaks Pkwy · San Jose, CA · 95134-1908
Is this the product you have?
- 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
- ChemistryIn vitro diagnostic medical device used to identify and quantify inorganic and organic compounds in the human body
- Lot codes and dates
TQH-MD-E0101THQ-MD-E-0102TQH-MD-E0103TQH-MD-E0104TQH-MD-EMP003TQH-MD-EMP-002
- Amount recalled
- 6 (5 in Us distribuion and 1 in Japan)
Where it was sold
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.
This product could cause temporary or reversible health problems — stop using it.
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