Device evidence

device-recall:cfres:111072

PHADIA Varelisa Cardiolipin IgM Cardiolipin autoantibody immunological test system (IgM class antibodies)

Official recall number

Z-2285-2012

Evidence summary

Product code: MID
Recall status: Terminated
Event initiated: August 02, 2012
Root cause: Labeling Change Control
Source snapshot: 5482458777762b1480c71ac49b2913b9c7984bb55aac66a4315d018da7cfed2c
Product: Z-2285-2012