ThinPrep CytoLyt Solution. Buffered Cell Wash Solution.

FDA device recall Z-1093-2026 · posted 2026-01-15 · Open, Classified

Recall details

Recalling firm

Hologic, Inc

Reason for recall

Fungal contamination of affected lot with Parengyodontium album.

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.

Root cause

Under Investigation by firm

Status

Open, Classified

Product code

LEA

Quantity affected

3,728 units

Distribution

US Nationwide distribution.

Date initiated

2025-12-12

Date posted

2026-01-15

Location

Marlborough, MA