Device evidence

device-recall:cfres:137172

Factor deficient plasma for the Siemens BCS¿ / BCS¿ XP System. In vitro diagnostic reagent for the determination of the activity of coagulation factor IX in human plasma by coagulometric methods.

Official recall number

Z-1713-2015

Evidence summary

Product code: GJT
Recall status: Terminated
Event initiated: May 11, 2015
Root cause: Under Investigation by firm
Source snapshot: 5482458777762b1480c71ac49b2913b9c7984bb55aac66a4315d018da7cfed2c
Product: Z-1713-2015