Medical device recalls Moderate risk

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

Recall date
December 12, 2025
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1093-2026
FDA classification
Class II
Brand / firm
Hologic, Inc
Sold / distributed
US Nationwide distribution.

Why it was recalled

Fungal contamination of affected lot with Parengyodontium album.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

ThinPrep¿ CytoLyt¿ Solution. Buffered Cell Wash Solution.

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