Drug recall
Panther Fusion SARS-CoV-2/Flu A/B/RSV Assay, REF: PRD-07400
FDA recall event 95731 · Class II · Hologic, Inc.
Key facts
| Event ID | 95731 |
|---|---|
| Recall numbers | Z-0694-2025 |
| Recalling firm | Hologic, Inc. |
| Product type | Devices |
| Products | Panther Fusion SARS-CoV-2/Flu A/B/RSV Assay, REF: PRD-07400 |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | SARS-CoV-2/Flu A/B/RSV Assay Kit may erroneously produce SARS-CoV-2 false positive results. |
| Initiation date | Nov 8, 2024 |
| Report date | Jan 1, 2025 |
| City | San Diego |
| State | CA |
| Country | United States |
| FEI number | 2024800 |
At a glance
- 1–9 Products in this recall
- 10–99 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: