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U.S. Department of Health and Human Services

Class 2 Device Recall ThinPrep CytoLyt Solution

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 Class 2 Device Recall ThinPrep CytoLyt Solutionsee related information
Date Initiated by FirmDecember 12, 2025
Date PostedJanuary 15, 2026
Recall Status1 Open3, Classified
Recall NumberZ-1093-2026
Recall Event ID 98058
Product Classification Preservative, cytological - Product Code LEA
ProductThinPrep CytoLyt Solution. Buffered Cell Wash Solution.
Code Information Catalog number: 0236004; UDI: (01)25420045508405(17)270303(10)5062EC; UDI-DI: 25420045508405; Lot number: 5062EC.
FEI Number 1000120743
Recalling Firm/
Manufacturer		 Hologic, Inc
250 Campus Dr
Marlborough MA 01752-3020
For Additional Information ContactThinPrep Technical Support
+1-800-4429892 Ext. 1
Manufacturer Reason
for Recall		Fungal contamination of affected lot with Parengyodontium album.
FDA Determined
Cause 2		Under Investigation by firm
ActionAn 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.
Quantity in Commerce3,728 units
DistributionUS Nationwide distribution.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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