Class 2 Device Recall PrepStain System

• Date Initiated by Firm: December 08, 2011
• Date Posted: July 26, 2012
• Recall Status: Terminated on November 08, 2013
• Recall Number: Z-2085-2012
• Recall Event ID: 62117
• PMA Number: P970018
• Product Classification: Processor, cervical cytology slide, automated - Product Code MKQ
• 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.
• Code Information: Catalog # 490670: These items are not serially tracked.
• Recalling Firm/ Manufacturer: Tripath Imaging, Inc.; 780 Plantation Dr; Burlington NC 27215-6723
• For Additional Information Contact: Elizabeth Gaipa; 919-206-7155
• Manufacturer 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.
• FDA Determined Cause: Nonconforming Material/Component
• Action: BD Diagnostics sent a letter dated March 2012 to all affected customers. The letter identifies the product, problem and actions that will be taken by the firm. Contact BD Diagnostics Technical Support at 1-877-822-7771, option 2 for questions regarding this letter.
• Quantity in Commerce: 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).
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• PMA Database: PMAs with Product Code = MKQ