FDA Device recall Z-2775-2016
Endura MD Mass Spectrometer u using software versions Endura MD Software 1.0 and 1.0 SP1. In vitro diagnostic medical device used to identi…
- FDA Device
- Class II
- terminated
- Published 2016-09-21
On 2016-09-21 the FDA classified a Class II recall of Endura MD Mass Spectrometer u using software versions Endura MD Software 1.0 and 1.0 SP1. In vitro diagnostic medical device used to identi… by Thermo Finnigan, citing 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.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2775-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-07-19 |
| Published | 2016-09-21 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Thermo Finnigan |
| Distribution | FL, NY |
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.
Identifiers
| code_info | TQH-MD-E0101, THQ-MD-E-0102, TQH-MD-E0103, TQH-MD-E0104, TQH-MD-EMP003, TQH-MD-EMP-002. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2775-2016%22
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