Z-1093-2026Class II

ThinPrep CytoLyt Solution. Buffered Cell Wash Solution

Name: Z-1093-2026 ThinPrep CytoLyt Solution. Buffered Cell Wash Solution
Creator: Hologic, Inc
Published: 2025-12-12
License: https://open.fda.gov/license/

Hologic, Inc. / initiated 2025-12-12 / Open, Classified / root cause: sterility

FDA source

Hologic, Inc began a recall of ThinPrep CytoLyt Solution. Buffered Cell Wash Solution on 2025-12-12. FDA classified it as Class II and gives the reason as "Fungal contamination of affected lot with Parengyodontium album". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as sterility.

Recall record

Recall number: Z-1093-2026
Classification: Class II
Status: Open, Classified
Initiated: 2025-12-12
Posted: 2026-01-15
Recalling firm: Hologic, Inc.
Product: ThinPrep CytoLyt Solution. Buffered Cell Wash Solution.
Product code: LEA Preservative, Cytological
Reason for recall: Fungal contamination of affected lot with Parengyodontium album.
Root cause tag: sterility
FDA 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 [email protected]. Consignees with questions about the recall notice are to contact their local Hologic Technical Support Representative.
Quantity in commerce: 3,728 units
Distribution: US Nationwide distribution.
Product codes and lots: Catalog number: 0236004; UDI: (01)25420045508405(17)270303(10)5062EC; UDI-DI: 25420045508405; Lot number: 5062EC.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1093-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1093-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-01-21	2026-01-15

Product code LEA

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)