Panther Fusion GBS Assay Kits with Weak Cartridge Seals May Produce Invalid Results
Hologic is recalling 380 Panther Fusion GBS Assay Kits due to potential weak pouch seals on the reagent cartridge. The seals may allow invalid or incorrect test results, potentially delaying necessary treatment.
- Product
- Panther Fusion GBS Assay REF PRD-04484 Kit containing Panther Fusion GBS Reagent Cartridge IVD.
- Category
- Medical Device
- Distribution
- 20 states