PrepStain Kit: 1.2 DiTi Cone. The PrepStain System is a liquid-based thin layer cell preparati...
FDA Recall #Z-2085-2012 — Class II — December 8, 2011
Product Description
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.
Reason for Recall
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.
Recalling Firm
Tripath Imaging, Inc. — Burlington, NC
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
18 units
Distribution
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).
Code Information
Catalog # 490670: These items are not serially tracked.
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated