Tripath PrepStain Slide Processor Recall for Leaking Cones and Incorrect Instructions
Tripath Imaging is recalling PrepStain Slide Processors because some 1.2 DiTi Cones leak and the kits contain incorrect preventive maintenance instructions.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II. The hazards involve leaking components and incorrect maintenance instructions, which are operational defects rather than direct biological or chemical contamination risks, fitting the Moderate severity criteria for low-risk contamination or labeling/instruction errors.
Plain-English summary
Tripath Imaging, Inc. is recalling 201 units of the PrepStain Slide Processor. The recall is due to a defect where some Prep Stain Kit 1.2 DiTi Cones have been found to be leaking. Additionally, the PrepStain Preparation kits contain incorrect preventive maintenance (PM) instructions.
The affected product is a liquid-based thin layer cell preparation process used to produce SurePath Slides for the screening and detection of cervical cancer, pre-cancerous lesions, and other cytologic categories. 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.
The recall covers units distributed worldwide, including the United States (nationwide, including Puerto Rico) and various international locations such as Belgium, Brazil, Canada, China, and others. The specific serial/lot numbers affected are listed in the agency's recall record. Users should contact Tripath Imaging for further instructions on how to handle the affected units.
The recalled product
- Product
- PrepStain Slide Processor. 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
- Manufacturer
- Tripath Imaging, Inc.
- Affected units
- 201
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- Catalog # 490100
- Serial/Lot #s: USPS200576
- USPS200577
- USPS200578
- USPS200583
- USPS200584
- USPS200585
- USPS200586
- USPS200587
- USPS200588
- USPS200589
- USPS200590
- USPS200591
- USPS200592
- USPS200593
- USPS200594
- USPS200595
- USPS200596
- USPS200597
- USPS200598
Distribution
Part of a larger recall action
This product is one of 4 recalled by Tripath Imaging, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 4 products in this recall →Related recalls
Same manufacturer · Tripath Imaging, Inc.
See all →- ModerateTripath PrepStain Kits Recalled for Leaking Cones and Incorrect Instructions
FDA (Devices) · 2012-08-01
- ModerateTripath PrepStain Kit 1.2 DiTi Cones Recalled for Leaking and Incorrect Instructions
FDA (Devices) · 2012-08-01
- ModerateTripath PrepStain Upgrade Kit Recalled for Leaking Cones and Incorrect Instructions
FDA (Devices) · 2012-08-01
- ModerateTripath PrepStain Syringing Pipettes Recalled for Leaking Defect
FDA (Devices) · 2012-06-27
- ModerateTripath PrepStain GYN 480 Test Kits Recalled for Leaking Pipettes
FDA (Devices) · 2012-06-27
Same hazard · leaking
See all →- HighStryker Ahto Tube Set Recalled for Handpiece Leaking During Use
FDA (Devices) · 2026-08-12
- HighStryker Strykeflow Suction/Irrigator PS Recalled for Leaking During Use
FDA (Devices) · 2026-08-12
- HighStryker Single Spike Tube Set Recalled for Leaking During Use
FDA (Devices) · 2026-08-12
- HighBD TEXIUM Closed Male Luer Devices Recalled for Leaking Interface Risk
FDA (Devices) · 2025-06-18
- ModerateMedline Sterile Water and Saline Bottles Recalled for Leaking
FDA (Devices) · 2025-05-07