Device evidence

device-recall:cfres:192684

Panther Fusion GBS Assay Cartridges 96 Tests, Catalog Number: PRD-04484. in vitro diagnostic test for group b streptococcus.

Official recall number

Z-0877-2022

Evidence summary

Product code: NJR
Recall status: Open, Classified
Event initiated: March 18, 2022
Root cause: Component change control
Source snapshot: 5482458777762b1480c71ac49b2913b9c7984bb55aac66a4315d018da7cfed2c
Product: Z-0877-2022