Recall Z-1093-2026
Hologic, Inc · initiated December 12, 2025
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
ThinPrep CytoLyt Solution. Buffered Cell Wash Solution.
Codes / lots: Catalog number: 0236004; UDI: (01)25420045508405(17)270303(10)5062EC; UDI-DI: 25420045508405; Lot number: 5062EC.
Reason for recall
Fungal contamination of affected lot with Parengyodontium album.
FDA-determined 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.
Details
- Recall number
- Z-1093-2026
- Initiated
- December 12, 2025
- Posted by FDA
- January 15, 2026
- Product code
- LEA – Preservative, Cytological
- Quantity
- 3,728 units
- Distribution
- US Nationwide distribution.
- Recalling firm
- Hologic, Inc, Marlborough, MA