FDA DevicesClass II
ThinPrep¿ CytoLyt¿ Solution. Buffered Cell Wash Solution.
Published: January 21, 2026Recall ID: Z-1093-2026Category: devicesCountry: US
Reason for Recall / Hazard
Fungal contamination of affected lot with Parengyodontium album.
Product Description & Identification
ThinPrep¿ CytoLyt¿ Solution. Buffered Cell Wash Solution.
Additional Source Details
| Field | Value |
|---|---|
| City | Marlborough |
| State | MA |
| Event id | 98058 |
| Address 1 | 250 Campus Dr |
| Code info | Catalog number: 0236004; UDI: (01)25420045508405(17)270303(10)5062EC; UDI-DI: 25420045508405; Lot number: 5062EC. |
| Postal code | 01752-3020 |
| Report date | 20260121 |
| Product type | Devices |
| Product quantity | 3,728 units |
| Reason for recall | Fungal contamination of affected lot with Parengyodontium album. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20251212 |
| Initial firm notification | Letter |
| Center classification date | 20260115 |
Overview
- Recalling FirmHologic, Inc
- StatusOngoing
- Risk LevelClass II
- DistributionUS Nationwide distribution.