FDAJuly 19, 2016device
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 o...
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
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 to do
FDA enforcement status: Terminated
Brands named
thermo finniganthermo
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
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- FDACascadion SM Clinical Analyzer, REF 99990000 SN Type: 99102021-02-01
- CPSCThermo Tents Recalls Mór Series Tents Due to Fire Hazard; Tents are Mislabeled as Fire Retardant (Recall Alert)2020-12-10
- FDASamco Bio-Tite Sterile Specimen Container, 120mL/53mm, Bio-Tite Blue Cap Catalog Number: 07 0006 The specimen containers are used for temporary collection, transfer, and/or storage of body fluids and solid specimen samples for the purpose of laboratory testing.2020-04-29
- FDACardinal Health Brand 120mL/53mm sterile, individual peel pouch specimen container with orange cap (100/pk) Catalog number: CHB139052019-07-18
- FDACardinal Health Brand 120mL/53mm sterile specimen container with orange cap, 75 pieces/pack, 4 packs/case Catalog number: CHB139042019-07-18
- FDAFisher Scientific Isotemp -General Purpose Water Bath: lsotemp 20L GP Bath Model Number: FSGPD202019-04-02
- FDAThermo Scientific General Purpose Dynamic Bath Precision 10L GP Bath Model Number: TSGP102019-04-02
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