Device evidence

device-recall:cfres:112538

Boule Con-Diff Hematology Control For in vitro diagnostic use as a control to monitor the performance of multi-parameter hematology instruments.

Official recall number

Z-0191-2013

Evidence summary

Product code: JPK
Recall status: Terminated
Event initiated: March 24, 2011
Root cause: Nonconforming Material/Component
Source snapshot: 5482458777762b1480c71ac49b2913b9c7984bb55aac66a4315d018da7cfed2c
Product: Z-0191-2013