FDAFDA · Food and drugs·Recall number Z-2251-2016
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.
Published August 3, 2016 · Recall initiated: May 6, 2016
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
It was discovered that both the new device and the predicate device failed to comply with performance standard.
What to do
FDA Mandated · Letter
Recall details
- Manufacturer
- BEST THERATRONICS LTD.
- Distributor
- Nationwide
- Lot
- All Raycell units with serial #'s 5000 and higher.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- Canada
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