FDAMay 6, 2016device

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.

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

It was discovered that both the new device and the predicate device failed to comply with performance standard.

What to do

FDA enforcement status: Terminated

Brands named

best theratronicsbest

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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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. — Recall Details · AllClear