FDA-Device2026-01-21Class IIPROCESSING DEFECT
Hologic ThinPrep CytoLyt Solution recalled for fungal contamination
What this means
Hologic's ThinPrep CytoLyt Solution (a buffered cell wash used in laboratory testing) from lot number 5062EC has been found to contain fungal contamination. The affected product was distributed nationwide. No injuries have been reported.
- Stop using lot 5062EC (check your catalog number 0236004 and UDI 25420045508405)
- Contact your supplier or Hologic for instructions on return or disposal
- Do not use this lot for patient samples
The agency's original wording
Hazard
Fungal contamination of affected lot with Parengyodontium album.
Intended for
All ages
Illnesses reported
None reported
Sold states
US Nationwide distribution.
Affected count
3,728 units
Manufactured in
250 Campus Dr, Marlborough, MA, United States
Products
ThinPrep¿ CytoLyt¿ Solution. Buffered Cell Wash Solution.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1093-2026Want us to check the next one for you?
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