Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

ThinPrep¿ CytoLyt¿ Solution. Buffered Cell Wash Solution. Recalled by Hologic, Inc Due to Fungal contamination of affected lot with Parengyodontium album.

Date: December 12, 2025
Company: Hologic, Inc
Status: Ongoing
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Hologic, Inc directly.

Affected Products

ThinPrep¿ CytoLyt¿ Solution. Buffered Cell Wash Solution.

Quantity: 3,728 units

Why Was This Recalled?

Fungal contamination of affected lot with Parengyodontium album.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Hologic, Inc

Hologic, Inc has 24 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report