FDA-Device2016-08-03Class II
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.
BEST THERATRONICS LTD.
Hazard
It was discovered that both the new device and the predicate device failed to comply with performance standard.
Sold states
Nationwide
Affected count
128
Manufactured in
413 MARCH ROAD, N/A, KANATA, N/A, Canada
Products
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 notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2251-2016Don't want to check this manually?
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