Recall Z-2086-2012— Tripath Imaging, Inc.
Class II · Terminated
Class II FDA medical device recall by Tripath Imaging, Inc., initiated 2011-12-08, terminated 2013-11-08. FDA's recall record names no specific 510(k) clearance for this event. 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.. 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..
- Recalling firm
- Tripath Imaging, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2011-12-08
- Terminated
- 2013-11-08
- Firm location
- Burlington, NC, United States
Product description
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.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.