BEST THERATRONICS LTD. recalls Best Theratronics cabinet x-ray systems intended for use in the irradiation of blood and blood products (packaged in tra

Recalled August 3, 2016 · FDA recall Z-2251-2016 · BEST THERATRONICS

Hazard

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

Units

128

Sold at

Nationwide

Description

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

Product

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.

Manufacturer(s)

BEST THERATRONICS LTD.

Made in

Canada

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →