Device evidence

device-recall:cfres:159896

UniCel DxC 600i SYNCHRON Access Clinical Systems; A25656, A25638. In vitro diagnostic device used for the quantitative, semi-quantitative, or qualitative determination of various analyte concentrations found in human body fluids.

Official recall number

Z-0310-2018

Evidence summary

Product code: JJE
Recall status: Terminated
Event initiated: November 06, 2017
Root cause: Device Design
Source snapshot: 5482458777762b1480c71ac49b2913b9c7984bb55aac66a4315d018da7cfed2c
Product: Z-0310-2018