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Sources: EU EUDAMED, US FDA
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Status: Terminated
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Best Theratronics cabinet x-ray systems intended for use in the irradiation of blood and blood products (packaged in transfusion bags) to inactivate T-lymphocytes for the prevention of Graft Versus Host Disease.
FDA Enforcement
Class II
·Terminated·BEST THERATRONICS LTD.·August 3, 2016
Best Theratronics cabinet x-ray systems intended for use in the irradiation of blood and blood products (packaged in transfusion bags) to inactivate T-lymphocytes for the prevention of Graft Versus Host Disease.
FDA Recall
Terminated
·BEST THERATRONICS LTD.·Product code MOT·May 6, 2016