FDA Medical Device Recalls (openFDA)
Hologic, Inc: ThinPrep CytoLyt Solution. Buffered Cell Wash Solution.
- Recall number
- Z-1093-2026
- Recalling firm
- Hologic, Inc
- Product
- ThinPrep CytoLyt Solution. Buffered Cell Wash Solution.
- Status
- Open, Classified
- Initiated
- 2025-12-12
- Posted
- 2026-01-15
- Terminated
- not on file
- Reason
- Fungal contamination of affected lot with Parengyodontium album.
- Root cause
- Under Investigation by 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 hologic-fa00286@iqvia.com. Consignees with questions about the recall notice are to contact their local Hologic Technical Support Representative.
- Quantity
- 3,728 units
- Distribution
- US Nationwide distribution.
- Lot, serial or model codes
- Catalog number: 0236004; UDI: (01)25420045508405(17)270303(10)5062EC; UDI-DI: 25420045508405; Lot number: 5062EC.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- LEA
- Firm FEI
- 1000120743
- Firm city
- Marlborough
- Firm state
- MA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28