FDAHealthDecember 12, 2025
Hologic, Inc — ThinPrep¿ CytoLyt¿ Solution. Buffered Cell Wash Solution.
⚠️ Fungal contamination of affected lot with Parengyodontium album.
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- December 12, 2025
US Nationwide distribution.
What's affected?
- Product
- ThinPrep¿ CytoLyt¿ Solution. Buffered Cell Wash Solution.
- Brand
- Hologic, Inc
- Lot code
- 5062EC
Additional details
Catalog number: 0236004; UDI: (01)25420045508405(17)270303(10)5062EC; UDI-DI: 25420045508405; Lot number: 5062EC.
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 3,728 units.
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