Drug recall
BIOFIRE FILMARRAY Pneumonia Panel plus, REF: RFIT-ASY-0143
FDA recall event 94942 · Class II · BioFire Diagnostics, LLC
Key facts
| Event ID | 94942 |
|---|---|
| Recall numbers | Z-2682-2024, Z-2683-2024 |
| Recalling firm | BioFire Diagnostics, LLC |
| Product type | Devices |
| Products | BIOFIRE FILMARRAY Pneumonia Panel plus, REF: RFIT-ASY-0143, BIOFIRE FILMARRAY Pneumonia Panel, REF: RFIT-ASY-0144 |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Pneumonia panels have an increased risk of control failures due to an issue in the manufacturing process, which could lead to delayed results for the customer. |
| Initiation date | Jun 10, 2024 |
| Report date | Aug 28, 2024 |
| 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: