BioFire Joint Infection (JI) Panel REF: RFIT-ASY-0138, 30 test Kit.
| Source | FDA Device Enforcement |
|---|---|
| Category | Medical Device |
| Severity | Medium |
| Status | ongoing |
| Recall date | April 22, 2026 |
| Reported | May 13, 2026 |
| Recalling firm | BioFire Diagnostics, LLC |
| Country / region | United States UT |
Hazard
Contamination to in-vitro diagnostic test may result in false positives.
Affected products
- BioFire Joint Infection (JI) Panel REF: RFIT-ASY-0138, 30 test Kit.
Related recalls
Swan-Ganz Jr Catheter, Models: SGPT54, SGPT64P, SGPT755PMedtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model 94215T; Cardiopulmonary bypass vMedtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model 94665; Cardiopulmonary bypass vaSwan-Ganz Catheter, Models: 131F7/131F7P, 131F7J, 141F7, 151F7, 834F75, 096F6/096F6P, C144F7, 782F75M, 132F5, Oncology Kit w/60" (152 cm) Appx 2.2 ml, Smallbore Ext Set w/ChemoLock Port, Clamp, Anti-Siphon Valve, Spiros;