Tripath PrepStain Kits Recalled for Leaking Cones and Incorrect Instructions
Tripath Imaging is recalling PrepStain 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 operational defects rather than direct biological contamination or acute physical injury risks, fitting the criteria for moderate severity.
Plain-English summary
Tripath Imaging, Inc. is recalling specific PrepStain kits, including the PrepStain PM Kit, T-AG and PrepStain PM Kit Europe, due to quality control issues. The recall involves 1,166 units of these liquid-based thin layer cell preparation kits, which are used to produce SurePath Slides for the screening and detection of cervical cancer and other cytologic categories.
The recall was initiated because some 1.2 DiTi cones found in the kits have been leaking. Additionally, the PrepStain Preparation kits contain incorrect preventive maintenance (PM) instructions. 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 products were distributed worldwide, including nationwide in the United States (including Puerto Rico) and in countries such as Belgium, Brazil, Canada, China, and Japan. Healthcare facilities and laboratories that have received these kits should stop using them and contact Tripath Imaging for further instructions.
The recalled product
- Product
- PrepStain PM Kit, T-AG (Catalog 490588); PrepStain PM Kit Europe (Catalog 490671); PrepStain Prep Only PM Kit, T-AG (Catalog 490954); PrepStain PM Kit XLP, T-US-II (Catalog 490424); PrepStain Prep PM Kit XLP T-US-II (Catalog 491118); PrepStain Prep Only PM Kit XLP, T-US-II (49042
- Manufacturer
- Tripath Imaging, Inc.
- Affected units
- 1,166
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 (6)
- SAP Part numbers: 490423
- 490424
- 490428
- 490588
- 490626
- 490954 and 490671.
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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