ThinPrep¿ CytoLyt¿ Solution — Class II medical device recall Z-1093-2026
Ongoing recall by Hologic, Inc, reported 2026-01-21, distributed nationwide. Fungal contamination of affected lot with Parengyodontium album.
| Recall number | Z-1093-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Hologic, Inc, Marlborough, MA, United States |
| Recall initiated | 2025-12-12 |
| Classified | 2026-01-15 |
| Reported by FDA | 2026-01-21 |
| Distributed | Nationwide (US) |
| Quantity | 3,728 units |
| Reason classes | microbial contamination |
| Pathogens | mold |
| UPC / GTIN / UDI-DI | 25420045508405 |
| Lot numbers | 5062EC |
| Model numbers | 0236004 |
Product
ThinPrep¿ CytoLyt¿ Solution. Buffered Cell Wash Solution.
Reason for recall
Fungal contamination of affected lot with Parengyodontium album.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1093-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.