Device evidence

device-recall:cfres:162740

Quidel MicroVue Intact PTH EIA, Model 8044. An enzyme immunoassay for the quantification of Intact Parathyroid Hormone (PTH) in serum.

Official recall number

Z-1520-2018

Evidence summary

Product code: CEW
Recall status: Terminated
Event initiated: October 26, 2016
Root cause: Nonconforming Material/Component
Source snapshot: 5482458777762b1480c71ac49b2913b9c7984bb55aac66a4315d018da7cfed2c
Product: Z-1520-2018