Endura MD Mass Spectrometer u using software versions recall: Software Issue
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…
Why was Endura MD Mass Spectrometer u using software versions 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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
TQH-MD-E0101, THQ-MD-E-0102, TQH-MD-E0103, TQH-MD-E0104, TQH-MD-EMP003, TQH-MD-EMP-002.
- 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…
- Recalling firm
- Thermo Finnigan LLC
- Quantity
- 6 (5 in Us distribuion and 1 in Japan)
- Distribution
- Worldwide distribution - US including FL, NY and Internationally to Japan.
- Recall date
- September 21, 2016
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)