Reported Aug 3, 2016 · Terminated
Best Theratronics cabinet x-ray systems intended for use in the irradiation of blood and blood products (packaged in…
Best Theratronics Ltd.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: BEST THERATRONICS LTD. · 413 MARCH ROAD · KANATA, N/A · N/A
Is this the product you have?
- 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.
- Lot codes and dates
- All Raycell units with serial #'s 5000 and higher.
- Amount recalled
- 128
Where it was sold
- Nationwide
Why it was recalled
It was discovered that both the new device and the predicate device failed to comply with performance standard.
This product could cause temporary or reversible health problems — stop using it.
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