Tripath PrepStain Kit 1.2 DiTi Cones Recalled for Leaking and Incorrect Instructions
Tripath Imaging is recalling 18 PrepStain Kit 1.2 DiTi Cones because some units are leaking 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, and the source text describes a defect (leaking and incorrect instructions) without reporting any specific injuries, illnesses, or deaths, fitting the criteria for a moderate severity recall.
Plain-English summary
Tripath Imaging, Inc. is recalling 18 units of the PrepStain Kit: 1.2 DiTi Cone. The 1.2 DiTi is a tip used in the PrepStain System, a liquid-based thin layer cell preparation process intended for the screening and detection of cervical cancer and other cytologic categories. The recall was initiated because some of the PrepStain Kit 1.2 DiTi Cones have been found to be leaking, and the PrepStain Preparation kits contain incorrect preventive maintenance (PM) instructions.
The affected units were distributed nationwide in the United States, including Puerto Rico, and in several international locations including Belgium, Brazil, Canada, China, Colombia, Hong Kong, India, Japan, Korea, Peru, Singapore, Taiwan, and Victoria (Australia). The items are identified by Catalog # 490670 and are not serially tracked.
Consumers and healthcare facilities should stop using the affected PrepStain Kit 1.2 DiTi Cones and contact Tripath Imaging, Inc. for further instructions or a replacement.
The recalled product
- Product
- 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 ot
- Manufacturer
- Tripath Imaging, Inc.
- Affected units
- 18
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 (1)
- Catalog # 490670: These items are not serially tracked.
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
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