Drug recall
Endura MD Mass Spectrometer u using software versions Endura MD Software 1.0 and 1.0 SP1. In vitro diagnostic…
FDA recall event 74837 · Class II · Thermo Finnigan LLC
Key facts
| Event ID | 74837 |
|---|---|
| Recall numbers | Z-2775-2016 |
| Recalling firm | Thermo Finnigan LLC |
| Product type | Devices |
| Products | 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… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| 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. |
| Initiation date | Jul 19, 2016 |
| Report date | Sep 21, 2016 |
| Termination date | Feb 21, 2017 |
| City | San Jose |
| State | CA |
| Country | United States |
| FEI number | 3003809634 |
At a glance
- 1–9 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: