FDA recall Z-1093-2026
Hologic, Inc · Class II · device
Product
ThinPrep¿ CytoLyt¿ Solution. Buffered Cell Wash Solution.
Reason for recall
Fungal contamination of affected lot with Parengyodontium album.
Distribution
US Nationwide distribution.
Key facts
- Status
- Ongoing
- Initiation date
- 2025-12-12
- Report date
- 2026-01-21
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- Marlborough, MA, United States
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1093-2026