FDA recall, , Moderate risk
Hologic ThinPrep CytoLyt Solution Buffered Cell Wash Solution
ThinPrep CytoLyt Solution, a buffered cell wash solution, is contaminated with Parengyodontium album.
Summary by Recall Canary from the FDA notice
What happened
Hologic, Inc., of Marlborough, Massachusetts, recalled 3,728 units of ThinPrep CytoLyt Solution, a buffered cell wash solution, due to fungal contamination of the affected lot with Parengyodontium album. The company began the recall on December 12, 2025, and the FDA added it to its Enforcement Report on January 15, 2026.
The product was distributed nationwide in the United States. The recall was classified by the FDA on January 15, 2026, and in the agency's weekly enforcement report on January 21, 2026.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
Match the UDI-DI and lot code listed under your product.
A UDI-DI is the device identifier printed with the barcode on the device label.
ThinPrep¿ CytoLyt¿ Solution. Buffered Cell Wash Solution.
- UDI-DI
- 25420045508405
- Lot code
- 5062EC
Recall details
- Company began the recall
- Sold in
US Nationwide distribution.
- Company
- Hologic, IncMarlborough, Massachusetts
- Hazard
- Contamination
- Risk
Moderate risk
Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 98058
- Recall number
- Z-1093-2026
- Quantity recalled
- 3,728 units
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
In FDA's weekly enforcement report
Listed on Recall Canary
