Thermo Fisher Recalls Endura MD Mass Spectrometer Software Due to Data Accuracy Defect
Thermo Fisher is recalling Endura MD Mass Spectrometer software versions 1.0 and 1.0 SP1 because a defect affects data accuracy.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II. The defect affects data accuracy, which is a significant quality issue but does not involve reported injuries, deaths, or immediate physical hazards like fire or choking.
Plain-English summary
Thermo Fisher has determined that the Endura MD mass spectrometer instrument control software versions 1.0 and 1.0 SP1 have a software defect which affects data accuracy. The Endura MD is an in vitro diagnostic medical device used to identify and quantify inorganic and organic compounds in the human body.
The recall involves 6 units, with 5 distributed in the US (including Florida and New York) and 1 in Japan. The affected software versions are 1.0 and 1.0 SP1.
Users of the affected devices should contact Thermo Fisher for instructions on how to resolve the software defect.
The recalled product
- 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…
- Manufacturer
- Thermo Finnigan LLC
- Hazard
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (6)
- TQH-MD-E0101
- THQ-MD-E-0102
- TQH-MD-E0103
- TQH-MD-E0104
- TQH-MD-EMP003
- TQH-MD-EMP-002.
Distribution
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