Recall Z-2251-2016— BEST THERATRONICS LTD.
Class II · Terminated
Class II FDA medical device recall by BEST THERATRONICS LTD., initiated 2016-05-06, terminated 2017-08-01. FDA's recall record names no specific 510(k) clearance for this event. 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.. Reason: It was discovered that both the new device and the predicate device failed to comply with performance standard..
- Recalling firm
- BEST THERATRONICS LTD.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2016-05-06
- Terminated
- 2017-08-01
- Firm location
- KANATA, N/A, Canada
Product description
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.
Reason for recall
It was discovered that both the new device and the predicate device failed to comply with performance standard.
Data sourced from openFDA. This site is unofficial and independent of the FDA.