ThinPrep¿ CytoLyt¿ Solution. Buffered Cell Wash Solution.
FDA Recall #Z-1093-2026 — Class II — December 12, 2025
Product Description
ThinPrep¿ CytoLyt¿ Solution. Buffered Cell Wash Solution.
Reason for Recall
Fungal contamination of affected lot with Parengyodontium album.
Recalling Firm
Hologic, Inc — Marlborough, MA
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
3,728 units
Distribution
US Nationwide distribution.
Code Information
Catalog number: 0236004; UDI: (01)25420045508405(17)270303(10)5062EC; UDI-DI: 25420045508405; Lot number: 5062EC.
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated