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U.S. Department of Health and Human Services

Class 2 Device Recall PrepStain System

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  Class 2 Device Recall PrepStain System see related information
Date Initiated by Firm December 08, 2011
Date Posted July 26, 2012
Recall Status1 Terminated 3 on November 08, 2013
Recall Number Z-2086-2012
Recall Event ID 62117
PMA Number P970018 
Product Classification Processor, cervical cytology slide, automated - Product Code MKQ
Product PrepStain Upgrade Kit: 1.3.0.3/1.2 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 # 491074: Serial/Lot # 110805MA   
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 2		 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 1274 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 and Original Applicant = BD Diagnostic Systems
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