Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
PrepStain Slide Processor. The PrepStain System is a liquid-based thin Recalled by Tripath Imaging, Inc. Due to Some Prep Stain Kit, 1.2 DiTi Cones have...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Tripath Imaging, Inc. directly.
Affected Products
PrepStain Slide Processor. The PrepStain System is a liquid-based thin layer cell preparation process. The PrepStain System produces SurePath Slides that are intended for use in the screening and detection of cervical cancer, pre-cancerous lesions, atypical cells and all other cytologic categories as defined by The Bethesda System for Reporting Cervical/Vaginal Cytology Diagnoses. The 1.2 DiTi is the tip on the PrepStain to which a pipette tip attaches and dispenses patient samples onto a glass microscope slide.
Quantity: 201 units
Why Was This Recalled?
Some Prep Stain Kit, 1.2 DiTi Cones have been found to be leaking and the PrepStain Preparation kits contain incorrect preventive maintenance (PM) instructions.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Tripath Imaging, Inc.
Tripath Imaging, Inc. has 9 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report