Official recall notice
FDA DeviceClass IINotable
FDA Recall: BioFire Joint Infection (JI) Panel REF: RFIT-ASY-0138, 30 test Kit.
- Recall date
- 2026-05-13
- Category
- Medical Device
- FDA class
- Class II
Why it was recalled
Hazard
Contamination to in-vitro diagnostic test may result in false positives.
Recommended action
What to do
106 kits (3,180 test)
Product description
Contamination to in-vitro diagnostic test may result in false positives.