Recall Z-1093-2026— Hologic, Inc

Name: FDA recall Z-1093-2026
Creator: U.S. Food and Drug Administration
Published: 2025-12-12

Class II · Ongoing

Class II FDA medical device recall by Hologic, Inc, initiated 2025-12-12. FDA's recall record names no specific 510(k) clearance for this event. Product: ThinPrep¿ CytoLyt¿ Solution. Buffered Cell Wash Solution.. Reason: Fungal contamination of affected lot with Parengyodontium album..

Recalling firm: Hologic, Inc
Classification: Class II
Status: Ongoing
Initiated: 2025-12-12
Firm location: Marlborough, MA, United States

Product description

ThinPrep¿ CytoLyt¿ Solution. Buffered Cell Wash Solution.

Reason for recall

Fungal contamination of affected lot with Parengyodontium album.

Data sourced from openFDA. This site is unofficial and independent of the FDA.