Device evidence

device-recall:cfres:172621

xTAG Gastrointestinal Pathogen Panel intended for the simultaneous qualitative detection and identification of multiple viral, bacterial and parasitic nucleic acids in human stool specimens or human stool (GPP) Kit, IVD, REF I032C0316.

Official recall number

Z-1767-2019

Evidence summary

Product code: PCH
Recall status: Open, Classified
Event initiated: February 22, 2019
Root cause: Nonconforming Material/Component
Source snapshot: 5482458777762b1480c71ac49b2913b9c7984bb55aac66a4315d018da7cfed2c
Product: Z-1767-2019