Device evidence

device-recall:cfres:117370

Iris Diagnostics Division iQ Control/Focus Set, Part Number 800-3104, Lot Number 153-12. Product Usage: For in vitro diagnostic use with the iQ200 series.

Official recall number

Z-1328-2013

Evidence summary

Product code: JJW
Recall status: Terminated
Event initiated: September 18, 2012
Root cause: Nonconforming Material/Component
Source snapshot: 5482458777762b1480c71ac49b2913b9c7984bb55aac66a4315d018da7cfed2c
Product: Z-1328-2013