Safety Enforcement Notice
Panther Fusion GBS Assay REF PRD-04484 Kit containing Panther Fusion GBS Reagent Cartridge IVD.
Issued for products by Hologic, Inc.
Recall Event Details
- Primary ID / Event Code
- Z-0907-2025
- Classification Code
- UDI-DI: 15420045510890, Kit Lot 715927, containing Cartridge Lot 624907, Exp. Date 2025-08-15.
- Manufacturer
- Hologic, Inc.
- Reported Date
- August 9, 2026