BioFire Respiratory Panel 2.1, IVD, REF: 423742 (30 test kit)
| Source | FDA Device Enforcement |
|---|---|
| Category | Medical Device |
| Severity | Medium |
| Status | ongoing |
| Recall date | October 22, 2025 |
| Reported | December 03, 2025 |
| Recalling firm | BioFire Diagnostics, LLC |
| Country / region | United States UT |
Hazard
Due to unintended movement of pouch chemistry, nucleic acid test may result in elevated risk of false negative results and risk of control failures.
Affected products
- BioFire Respiratory Panel 2.1, IVD, REF: 423742 (30 test kit)
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