Thermo Finnigan LLC: Medical Device Recall in 2016 - (Recall #: Z-2775-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: July 19, 2016

Date Posted: September 21, 2016

Recall Number: Z-2775-2016

Event ID: 74837

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.

Status: Terminated

Product Quantity: 6 (5 in Us distribuion and 1 in Japan)

Code Information:

TQH-MD-E0101, THQ-MD-E-0102, TQH-MD-E0103, TQH-MD-E0104, TQH-MD-EMP003, TQH-MD-EMP-002.

Distribution Pattern:

Worldwide distribution - US including FL, NY and Internationally to Japan.

Voluntary or Mandated:

Voluntary: Firm initiated