Drug recall
FilmArra Pneumonia Panel plus (Pneumoplus), REF: RFIT-LBL-0374
FDA recall event 96346 · Class II · BioFire Diagnostics, LLC
Key facts
| Event ID | 96346 |
|---|---|
| Recall numbers | Z-1518-2025 |
| Recalling firm | BioFire Diagnostics, LLC |
| Product type | Devices |
| Products | FilmArra Pneumonia Panel plus (Pneumoplus), REF: RFIT-LBL-0374 |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Increased risk of control failures and false negative test results with multiplexed nucleic acid test. |
| Initiation date | Feb 27, 2025 |
| Report date | Apr 16, 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: