Device product
Panther Fusion GBS Assay REF PRD-04484 Kit containing Panther Fusion GBS Reagent Cartridge IVD.
Z-0907-2025
Product summary
- Firm
- Hologic, Inc.
- Event
- Event 95948
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 380
- Official record key
device-enforcement:Z-0907-2025
Official wording
Reason: Potential weak pouch seal on Panther Fusion GBS assay cartridge, causing potential for invalid or incorrect results leading to a possible delay of treatment.
Code information: UDI-DI: 15420045510890, Kit Lot 715927, containing Cartridge Lot 624907, Exp. Date 2025-08-15.
Distribution pattern: AR, CA, CT, FL, IN, KS, LA, MA, ME, MI, NC, NJ, NV, NY, PR, TX, UT, VT, WA, WV, and Canada.
Derived failure modes
-
Labeling or packaging
weak pouch