ThinPrep CytoLyt Solution. Buffered Cell Wash Solution.
Recall
- Recall Number
- Z-1093-2026
- Event Number
- 98058
- Firm
- Hologic, Inc
- FEI Number
- 1000120743
- Product Code
- LEA
- Status
- Open, Classified
- Root Cause
- Under Investigation by firm
- Initiated
- December 12, 2025
- Posted
- January 15, 2026
- Address
- 250 Campus Dr, Marlborough, MA, 01752-3020
Description
ThinPrep CytoLyt Solution. Buffered Cell Wash Solution.
Fungal contamination of affected lot with Parengyodontium album.
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 [email protected]. Consignees with questions about the recall notice are to contact their local Hologic Technical Support Representative.
US Nationwide distribution.
3,728 units