Reviewer
KW
K. Watanabe

IBL Anti-CCP Kit Reuse - FR

Tier 3

HCP email · Submitted by Camille Rousseau · France · 2026-06-29

Asset ID
A-1045
AI classification

Communication proposes a kit reuse protocol not covered by the current IFU. Confidence: high. Suggested tier: Tier 3.

Confidence
high
Suggested tier
Tier 3
Model
halogen-mlr-v4
Detected red flags
  • Reuse instruction outside IFU
  • Diagnostic claim modification
  • Missing IVDR disclosure
[ Asset preview — HCP email ]