Drug recall
BioFire Respiratory Panel 2.1 plus Kit, REF: 423740, For Filmarray systems
FDA recall event 96835 · Class II · BioFire Diagnostics, LLC
Key facts
| Event ID | 96835 |
|---|---|
| Recall numbers | Z-1877-2025 |
| Recalling firm | BioFire Diagnostics, LLC |
| Product type | Devices |
| Products | BioFire Respiratory Panel 2.1 plus Kit, REF: 423740, For Filmarray systems |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Due to manufacturing error, respiratory panel may result in elevated control failures and/or false negative results. |
| Initiation date | Apr 30, 2025 |
| Report date | Jun 4, 2025 |
| City | Salt Lake City |
| State | UT |
| Country | United States |
| FEI number | 3002773840 |
At a glance
- 1–9 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: