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Recall Observatory FDA recall evidence

Device product

PrepStain Kit: 1.2 DiTi Cone. 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.

Z-2085-2012

December 08, 2011

Class II

Product summary

Firm
Tripath Imaging, Inc.
Event
Event 62117
Status
Terminated
Classification
Class II
Quantity
18 units
Official record key
device-enforcement:Z-2085-2012

Official wording

Reason: 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.

Code information: Catalog # 490670: These items are not serially tracked.

Distribution pattern: Worldwide Distribution-USA (nationwide) including Puerto Rico and the states AL, AK, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, ME, MD, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, WY, and WV and the countries of Belgium, Brazil, Canada, China, Columbia, Hong Kong, India, Japan, Korea, Peru, Singapore, Taiwan and Victoria (Australia).

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.