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Open, Classified

ThinPrep CytoLyt Solution. Buffered Cell Wash Solution.

FDA Recall Z-1093-2026 · Posted 2026-01-15

Recalling FirmHologic, Inc
Recall StatusOpen, Classified
Product CodeLEA
Date Initiated2025-12-12
Product Quantity3,728 units

Reason for Recall

Fungal contamination of affected lot with Parengyodontium album.

Firm Action

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.

Root Cause

Under Investigation by firm

Distribution Pattern

US Nationwide distribution.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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