Hologic, Inc. recalled 3,728 units of ThinPrep CytoLyt Solution on December 12, 2025. The recall follows the discovery of fungal contamination with Parengyodontium album. Patients and healthcare providers must stop using the affected products immediately.
Fungal contamination of affected lot with Parengyodontium album.
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Hologic, Inc or your healthcare provider for instructions. Notification method: Letter
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The recalled product is ThinPrep CytoLyt Solution, catalog number 0236004, with lot number 5062EC. It is distributed nationwide across the United States. Specific identifiers include UDI: (01)25420045508405(17)270303(10)5062EC.
The contamination with Parengyodontium album poses a high health risk. This fungal pathogen can lead to serious health complications if used in medical procedures.
As of now, there are no reported injuries or adverse events associated with the use of the contaminated product. The recall aims to prevent potential health risks.
Stop using the ThinPrep CytoLyt Solution immediately. Contact Hologic, Inc. or your healthcare provider for further instructions and details on the recall.
For assistance, reach Hologic, Inc. via their website or call their customer support. Additional information can be found at the FDA recall notice: https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=Z-1093-2026.
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