FDA Device recall Z-2086-2012
PrepStain Upgrade Kit: 1.3.0.3/1.2 DiTi Cone
- FDA Device
- Class II
- terminated
- Published 2012-08-01
On 2012-08-01 the FDA classified a Class II recall of PrepStain Upgrade Kit: 1.3.0.3/1.2 DiTi Cone by Tripath Imaging, citing 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.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2086-2012 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2011-12-08 |
| Published | 2012-08-01 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Tripath Imaging |
| Distribution | US |
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.
Identifiers
| code_info | Catalog # 491074: Serial/Lot # 110805MA |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2086-2012%22
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