Z-1093-2026 Class II Ongoing
FDA device recall Z-1093-2026 was initiated by Hologic, Inc on December 12, 2025 and is designated Class II. Reason for recall: Fungal contamination of affected lot with Parengyodontium album. The recall status is ongoing. Affected quantity: 3,728 units.
Recall Details
- Product Type
- Devices
- Report Date
- January 21, 2026
- Initiation Date
- December 12, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 3,728 units
Product Description
ThinPrep¿ CytoLyt¿ Solution. Buffered Cell Wash Solution.
Reason for Recall
Fungal contamination of affected lot with Parengyodontium album.
Distribution Pattern
US Nationwide distribution.
Code Information
Catalog number: 0236004; UDI: (01)25420045508405(17)270303(10)5062EC; UDI-DI: 25420045508405; Lot number: 5062EC.