Drug recall
Panther Fusion GBS Assay REF PRD-04484 Kit containing Panther Fusion GBS Reagent Cartridge IVD.
FDA recall event 95948 · Class II · Hologic, Inc.
Key facts
| Event ID | 95948 |
|---|---|
| Recall numbers | Z-0907-2025 |
| Recalling firm | Hologic, Inc. |
| Product type | Devices |
| Products | Panther Fusion GBS Assay REF PRD-04484 Kit containing Panther Fusion GBS Reagent Cartridge IVD. |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Potential weak pouch seal on Panther Fusion GBS assay cartridge, causing potential for invalid or incorrect results leading to a possible delay of treatment. |
| Initiation date | Dec 13, 2024 |
| Report date | Jan 22, 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: