[pending] ThinPrep¿ CytoLyt¿ Solution. Buffered Cell Wash Solution.
Pending LLM rewrite. Source: FDA_DEVICE Z-1093-2026.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Pending LLM scoring against the rubric.
Plain-English summary
Fungal contamination of affected lot with Parengyodontium album.
The recalled product
- Product
- ThinPrep¿ CytoLyt¿ Solution. Buffered Cell Wash Solution.
- Manufacturer
- Hologic, Inc
- Category
- Medical Device — Devices
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- Catalog number: 0236004
- UDI: (01)25420045508405(17)270303(10)5062EC
- UDI-DI: 25420045508405
- Lot number: 5062EC.
Distribution
Distributed nationwide across the United States.
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