← FDA ENFORCEMENT
Z-1093-2026Class II
Hologic, Inc
What this record is not
A recall record is reproduced as FDA published it, and the classification is FDA’s. SPEQ adds no interpretation, and a recall concerns the products and dates in the record — it is not a statement about a company’s other products or its current status.
Recalling firm
Hologic, Inc
Product type
Device
Status
Ongoing
Report date
2026-01-21
Distribution
US Nationwide distribution.
Firm state
MA
Product quantity
3,728 units
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Environmental MonitoringReason for recall
Fungal contamination of affected lot with Parengyodontium album.
Product description
ThinPrep¿ CytoLyt¿ Solution. Buffered Cell Wash Solution.
Code / lot info
Catalog number: 0236004; UDI: (01)25420045508405(17)270303(10)5062EC; UDI-DI: 25420045508405; Lot number: 5062EC.
Data: U.S. FDA. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification. Open the enforcement explorer →