Recall
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.
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.

View original FDA notice →

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