Device product
ThinPrep¿ CytoLyt¿ Solution. Buffered Cell Wash Solution.
Z-1093-2026
Product summary
- Firm
- Hologic, Inc
- Event
- Event 98058
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 3,728 units
- Official record key
device-enforcement:Z-1093-2026
Official wording
Reason: Fungal contamination of affected lot with Parengyodontium album.
Code information: Catalog number: 0236004; UDI: (01)25420045508405(17)270303(10)5062EC; UDI-DI: 25420045508405; Lot number: 5062EC.
Distribution pattern: US Nationwide distribution.
Derived failure modes
-
Microbial contamination
Fungal contamination