Tripath PrepStain Upgrade Kit Recalled for Leaking Cones and Incorrect Instructions
Tripath Imaging is recalling PrepStain Upgrade Kits 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 functional defects rather than direct biological contamination or immediate physical injury risks, fitting the criteria for moderate severity.
Plain-English summary
Tripath Imaging, Inc. is recalling 1,274 units of the PrepStain Upgrade Kit: 1.3.0.3/1.2 DiTi Cone. The recall is due to reports that some 1.2 DiTi Cones have been found to be leaking. Additionally, the PrepStain Preparation kits contain incorrect preventive maintenance (PM) instructions.
The PrepStain System is a liquid-based thin layer cell preparation process used to produce SurePath Slides. These slides are intended for the screening and detection of cervical cancer, pre-cancerous lesions, atypical cells, 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 affected units were distributed nationwide in the United States, including Puerto Rico, and internationally to Belgium, Brazil, Canada, China, Columbia, Hong Kong, India, Japan, Korea, Peru, Singapore, Taiwan, and Victoria (Australia). The specific catalog number is 491074 and the serial/lot number is 110805MA. Users should contact Tripath Imaging for further instructions on how to proceed with the recall.
The recalled product
- 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
- Manufacturer
- Tripath Imaging, Inc.
- Affected units
- 1,274
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 # 491074: Serial/Lot # 110805MA
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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See all →- ModerateTripath PrepStain Kits Recalled for Leaking Cones and Incorrect Instructions
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