Cell wash solution recalled over fungal contamination of an affected lot
Hologic is recalling 3,728 units of ThinPrep CytoLyt Solution over fungal contamination of the affected lot with Parengyodontium album.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Scored 3 under the risk-of-harm criterion: the record states fungal contamination of a laboratory solution, and no injuries are reported.
Plain-English summary
ThinPrep CytoLyt Solution, a buffered cell wash solution, catalog number 0236004, is being recalled by Hologic, Inc.
The reason given in the enforcement record is fungal contamination of the affected lot with Parengyodontium album.
The record lists 3,728 units carrying UDI-DI 25420045508405, from the lot recorded in the enforcement record. Distribution was nationwide in the United States. The FDA has classified the action as Class II.
The enforcement record reports no injuries. Laboratories should quarantine the affected lot and follow Hologic's instructions.
The recalled product
- Product
- ThinPrep¿ CytoLyt¿ Solution. Buffered Cell Wash Solution.
- Manufacturer
- Hologic, Inc
- Affected units
- 3,728
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- Catalog number: 0236004
- UDI: (01)25420045508405(17)270303(10)5062EC
- UDI-DI: 25420045508405
- Lot number: 5062EC.
Distribution
Distributed nationwide across the United States.
Related recalls
Same manufacturer · Hologic, Inc
See all →- SevereHologic Selenia Dimensions Mammography Systems Loose Internal Bolts
FDA (Devices) · 2026-05-20
- ModerateHologic 3DIMENSIONS MAMMOGRAPHY SYSTEM medical device recall
FDA (Devices) · 2026-05-20
- ModerateGenius Review Station Display Modified Outside Validated Configuration
FDA (Devices) · 2026-05-06
- HighHologic Aptima HPV assay may produce invalid or false negative results
FDA (Devices) · 2026-03-25
- HighBreast biopsy needles recalled over particulates that can enter tissue
FDA (Devices) · 2026-02-18
Same hazard · fungal contamination
See all →- CriticalMedline Convenience Kits Recalled for Fungal Contamination Risk
FDA (Devices) · 2026-09-23
- CriticalMedline Convenience Kits Recalled for Potential Fungal Contamination
FDA (Devices) · 2026-09-23
- SevereMedline Convenience Kits Recalled for Fungal Contamination Risk
FDA (Devices) · 2026-09-23
- CriticalMedline Convenience Kits Recalled for Potential Fungal Contamination
FDA (Devices) · 2026-09-23
- CriticalMedline Recalls Blood and Urine Collection Kits Due to Fungal Contamination
FDA (Devices) · 2026-09-23
Similar recalls
- CriticalMedline Recalls Blood and Urine Collection Kits Due to Fungal Contamination
FDA (Devices) · 2026-09-23
- SevereFranck's Lab Recalls Sterile Vanadyl Sulfate Injectable Due to Contamination
FDA (Drugs) · 2012-08-22
- SevereCarefusion Recalls ChloraPrep Applicators Due to Incomplete Seals
FDA (Drugs) · 2012-09-26
- HighMedline Blood Culture Kits Recalled Due to Potential Seal Defects
FDA (Devices) · 2026-09-09
- HighBioseal Central Line Dressing Kits Recalled for Mold Contamination
FDA (Devices) · 2021-05-26
- SevereChloraPrep One-Step Topical Drug Recalled for Fungal Contamination
FDA (Drugs) · 2025-03-19