⚠ RecallRadar📷 ScanGuidesOfficial U.S. recall notices, restated plainly

Hologic, Inc: ThinPrep¿ CytoLyt¿ Solution. Buffered Cell Wash Solution.

Medical DevicesSource: FDA (device) · Date: 2026-01-21

Read the official notice at FDA (device) →

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The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.

Company / brand
Hologic, Inc
Product
ThinPrep¿ CytoLyt¿ Solution. Buffered Cell Wash Solution.
Reason / hazard
Fungal contamination of affected lot with Parengyodontium album.
Classification
Class II
Status
Ongoing
Distribution / sold at
US Nationwide distribution.
Recall initiated
2025-12-12
Code info
Catalog number: 0236004; UDI: (01)25420045508405(17)270303(10)5062EC; UDI-DI: 25420045508405; Lot number: 5062EC.
Product quantity
3,728 units
Voluntary mandated
Voluntary: Firm initiated
City
Marlborough
State
MA
Country
United States
Event id
98058
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