ThinPrep CytoLyt Solution. Buffered Cell Wash Solution.
- Company
- Hologic, Inc
- Recall Initiated
- December 12, 2025
- Posted
- January 15, 2026
- Recall Number
- Z-1093-2026
- Quantity
- 3,728 units
- Firm Location
- Marlborough, MA
Reason for Recall
Fungal contamination of affected lot with Parengyodontium album.
Distribution
US Nationwide distribution.
Lot / Code Info
Catalog number: 0236004; UDI: (01)25420045508405(17)270303(10)5062EC; UDI-DI: 25420045508405; Lot number: 5062EC.
Root Cause
Under Investigation by firm
Action Taken
An URGENT MEDICAL DEVICE RECALL NOTIFICATION was mailed to consignees on 12/12/25. The notification informs consignees that Hologic will provide replacement bottles of ThinPrep CytoLyt Solution to affected customers from unaffected lots based on retained sample testing. Consignees are asked to inspect their inventory for affected product and discontinue use immediately. Affected product is to be quarantined and destroyed per routine laboratory disposal procedures. Consignees are asked to complete the Customer Response Form using the provided QR Code and Hologic will coordinate replacement. Consignees can contact IQVIA MedTech for assistance with response forms at 855-620-6108 or by email at hologic-fa00286@iqvia.com. Consignees with questions about the recall notice are to contact their local Hologic Technical Support Representative.