FDA Device recall Z-1093-2026
ThinPrep¿ CytoLyt¿ Solution
- FDA Device
- Class II
- ongoing
- Published 2026-01-21
On 2026-01-21 the FDA classified a Class II recall of ThinPrep¿ CytoLyt¿ Solution by Hologic, citing fungal contamination of affected lot with Parengyodontium album.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1093-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-12-12 |
| Published | 2026-01-21 |
| Last updated | 2026-09-13 11:58 UTC |
| Company | Hologic |
| Distribution | US |
Product
ThinPrep¿ CytoLyt¿ Solution. Buffered Cell Wash Solution.
Reason
Fungal contamination of affected lot with Parengyodontium album.
Identifiers
| code_info | Catalog number: 0236004; UDI: (01)25420045508405(17)270303(10)5062EC; UDI-DI: 25420045508405; Lot number: 5062EC. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:58 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1093-2026%22
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