ThinPrep¿ CytoLyt¿ Solution. Buffered Cell Wash Solution. recall (Hologic, Inc)
Medical deviceClass IIOngoing
Summary: Hologic, Inc is recalling ThinPrep¿ CytoLyt¿ Solution. Buffered Cell Wash Solution.. Reason: Fungal contamination of affected lot with Parengyodontium album.
What is being recalled
ThinPrep¿ CytoLyt¿ Solution. Buffered Cell Wash Solution.
Why
Fungal contamination of affected lot with Parengyodontium album.
How serious is it
Class II is the middle level: using or being exposed to this product may cause temporary or medically reversible health problems, and the chance of serious harm is remote.
Where it was sold
US Nationwide distribution.
How to tell if yours is affected
Catalog number: 0236004; UDI: (01)25420045508405(17)270303(10)5062EC; UDI-DI: 25420045508405; Lot number: 5062EC.
What to do
Check the model, lot or serial numbers above against your device. If yours is affected, contact the manufacturer or your healthcare provider before you stop using a device you rely on.
Recall facts
| Recall number | Z-1093-2026 |
| Category | Medical device |
| Agency | U.S. Food and Drug Administration (FDA) |
| Severity | Class II |
| Status | Ongoing |
| Recall started | December 12, 2025 |
| Reported | January 21, 2026 |
| Company | Hologic, Inc |
| Company location | Marlborough, MA, United States |
| Initiated by | Voluntary: Firm initiated |
| Quantity | 3,728 units |
More recalls from Hologic, Inc · all medical device recalls · recalls from December 2025