Skip to content
Recall Observatory FDA recall evidence

Device evidence

device-recall:cfres:212709

Helix Elite" Inactivated Standard: Inactivated SARS-CoV-2 Whole Virus (Pellet), Multi-analyte, unassayed quality control material, Catalog Number HE0065N

Official recall number

Z-1371-2025

Evidence summary

Product code
OHQ
Recall status
Open, Classified
Event initiated
February 20, 2025
Root cause
Process control
Source snapshot
5482458777762b1480c71ac49b2913b9c7984bb55aac66a4315d018da7cfed2c
Product
Z-1371-2025

Field note

Send feedback

We'll only use this to respond to your feedback.