Device evidence

device-recall:cfres:111837

Dimension Vista(R) Systems Vista(R) Theophylline THEO Flex(R) Regent Cartridge (K4071) The THEO method is an in vitro diagnostic test for the quantitative measurement of Theophylline in human serum and plasma on the Dimension Vista(R) system.

Official recall number

Z-0408-2013

Evidence summary

Product code: KLS
Recall status: Terminated
Event initiated: August 09, 2012
Root cause: Nonconforming Material/Component
Source snapshot: 5482458777762b1480c71ac49b2913b9c7984bb55aac66a4315d018da7cfed2c
Product: Z-0408-2013