Tripath PrepStain Installation Kit Recalled for Leaking Pipettes
Tripath Imaging is recalling PrepStain Installation Kits because leaking syringing pipettes may fail to dispense the minimum required sample volume.
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 III, which is defined as unlikely to cause adverse health consequences. The defect results in a functional failure (insufficient sample volume) rather than a direct physical injury hazard, fitting the criteria for a moderate severity score.
Plain-English summary
Tripath Imaging, Inc. is recalling the PrepStain Installation Kit (PreCoat), Catalog/Model # 490528. The recall involves 46,112,784 units distributed worldwide. The specific lot codes associated with this recall are 100917ry, 101105sh, and 110107rg.
The recall was initiated because the PrepStain Syringing Pipettes included in the kit may leak. This defect can prevent the pipettes from dispensing the minimum required volume of 7.5 mL of the sample. The company noted that this event resulted in an increase in complaints regarding leaking syringing pipettes.
Users of these kits should stop using the affected pipettes and contact Tripath Imaging for further instructions or a replacement.
The recalled product
- Product
- PrepStain Installation Kit (PreCoat), Catalog/Model # 490528
- Manufacturer
- Tripath Imaging, Inc.
- 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 (3)
- 100917ry
- 101105sh
- 110107rg
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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