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
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