ThinPrep CytoLyt Solution. Buffered Cell Wash Solution recallZ-1093-2026 · Hologic, Inc · initiated Dec 12, 2025
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Hologic, Inc or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Fungal contamination of affected lot with Parengyodontium album.
FDA root cause category: Under Investigation by firm
What the company is doing
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.
Recall details
- Recall number
- Z-1093-2026
- Status
- Open, Classified
- Initiated by the company
- Dec 12, 2025
- Posted by the FDA
- Jan 15, 2026
- Recalling firm
- Hologic, Inc
- Quantity
- 3,728 units
- Product code
- LEA
- Distribution
- US Nationwide distribution.
Product description
ThinPrep CytoLyt Solution. Buffered Cell Wash Solution.
Code information (models, lots, serial numbers)
Catalog number: 0236004; UDI: (01)25420045508405(17)270303(10)5062EC; UDI-DI: 25420045508405; Lot number: 5062EC.
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- ThinPrep® ThinPrep® CytoLyt® Sol'n 946mlHologic, Inc. · PRESERVATIVE, CYTOLOGICAL1 recall1 report
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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