Tripath PrepStain Syringing Pipettes Recalled for Leaking Defect
Tripath Imaging is recalling PrepStain Syringing Pipettes 240 because they may leak and fail to dispense the minimum required sample volume.
The agency’s classification
FDA (Devices): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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 III, which is defined as unlikely to cause adverse health consequences. The defect involves a functional failure (leaking) rather than a direct safety hazard like injury or contamination.
Plain-English summary
Tripath Imaging, Inc. is recalling PrepStain Syringing Pipettes 240 (Catalog #490517) due to a defect where the pipettes may leak. This issue can prevent the device from dispensing the minimum volume of 7.5 mL of the sample.
The recall covers 46,112,784 units distributed worldwide. The event was initiated following an increase in complaints regarding leaking syringing pipettes.
Users of these products should stop using them and contact Tripath Imaging for further instructions.
The recalled product
- Product
- PrepStain Syringing Pipettes 240 (Catalog #490517)
- Manufacturer
- Tripath Imaging, Inc.
- Hazard
- Affected units
- 46,112,784
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)
- 100901a
- 100902f
- 100903d
- 100908c
- 100910c
- 100914f
- 100916d
- 100921d
- 100928c
- 101005a
- 101007d
- 101008c
- 101012c
- 101013a
- 101015c
- 101020d
- 101022c
- 101027a
- 101028c
- 101029d
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 5 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 5 products in this recall →Related recalls
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