Hologic, Inc recalls ThinPrep¿ CytoLyt¿ Solution. Buffered Cell Wash Solution.

Fungal contamination of affected lot with Parengyodontium album.

ThinPrep¿ CytoLyt¿ Solution. Buffered Cell Wash Solution.

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.

• FDA enforcement recordOfficial FDA database entry for Z-1093-2026
• FDA device classification · LEAOfficial FDA classification for this device type
• CFR regulation · 21 CFR 864.4010The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find Hologic, IncSearch for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.