Device evidence

device-recall:cfres:115860

Access Immunoassay System; P/N 107405S Product Usage: The Access Immunoassay Systems are in vitro diagnostic devices used for the quantitative, semi-quantitative or qualitative determination of various analyte concentrations found in human body fluids.

Official recall number

Z-1032-2013

Evidence summary

Product code: JJE
Recall status: Terminated
Event initiated: February 12, 2013
Root cause: Device Design
Source snapshot: 5482458777762b1480c71ac49b2913b9c7984bb55aac66a4315d018da7cfed2c
Product: Z-1032-2013