Class II
Medical Device Recall: ThinPrep¿ CytoLyt¿ Solution. Buffered Cell Wash Solution.
Hologic, Inc · December 12, 2025
Reason for Recall
Fungal contamination of affected lot with Parengyodontium album.
Distribution
US Nationwide distribution.
States Affected
NATIONWIDE
Quantity Affected
3,728 units
Source: FDA (openFDA Device Enforcement)
Recall number: Z-1093-2026
Status: ongoing
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