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Z-2085-2012 Class II Terminated

Recalled by Tripath Imaging, Inc. — Burlington, NC

FDA device recall Z-2085-2012 was initiated by Tripath Imaging, Inc. on December 8, 2011 and is designated Class II. 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. The recall status is terminated (terminated November 8, 2013). Affected quantity: 18 units.

Recall Details

Product Type: Devices
Report Date: August 1, 2012
Initiation Date: December 8, 2011
Termination Date: November 8, 2013
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 18 units

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.

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).

Code Information

Catalog # 490670: These items are not serially tracked.

Other recalls by Tripath Imaging, Inc.

Z-1814-2012 Class III — Manual Method 1: 480 Test Kit (PreCoat), Catalog/Model # 490529 (March 22, 2012)
Z-1813-2012 Class III — PrepStain Installation Kit (PreCoat), Catalog/Model # 490528 (March 22, 2012)
Z-1815-2012 Class III — PrepStain GN 480 Disposable Kit Catalog/Model 490542 This is a complete kit, pe (March 22, 2012)
Z-1811-2012 Class III — PrepStain Syringing Pipettes 240 (Catalog #490517) (March 22, 2012)
Z-1812-2012 Class III — PrepStain GYN 480 Disposable Test Kit with PreCoat Slides (Catalog #490523 (March 22, 2012)
Z-2088-2012 Class II — PrepStain PM Kit, T-AG (Catalog 490588); PrepStain PM Kit Europe (Catalog 490671 (December 8, 2011)
Z-2086-2012 Class II — PrepStain Upgrade Kit: 1.3.0.3/1.2 DiTi Cone. The PrepStain System is a liqui (December 8, 2011)
Z-2087-2012 Class II — PrepStain Slide Processor. The PrepStain System is a liquid-based thin layer (December 8, 2011)