FDA-Device2026-01-21Class IIPROCESSING DEFECT

Hologic ThinPrep CytoLyt Solution recalled for fungal contamination

OTHERNationwide distribution

Stop using Hologic ThinPrep CytoLyt Solution

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

Hazard

Fungal contamination of affected lot with Parengyodontium album.

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-1093-2026

More Hologic, Inc recalls

FDA-Device2026-05-20
Hologic Selenia Dimensions mammography systems recalled for loose or broken internal bolts
FDA-Device2026-05-20
Hologic 3DIMENSIONS mammography systems recalled for loose or broken internal bolts

Don't want to check this manually?

We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.

Get the Sunday Brief