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-E0101
    • THQ-MD-E-0102
    • TQH-MD-E0103
    • TQH-MD-E0104
    • TQH-MD-EMP003
    • TQH-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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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Feb 21, 2017 · Data as of Sep 19, 5:59 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.