Tripath Imaging Recalls 480 Test Kits Due to Leaking Pipettes
Tripath Imaging is recalling Manual Method 1: 480 Test Kits because the PrepStain Syringing Pipettes may leak and fail to dispense the minimum required volume.
What this means for you
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as FDA Class III, which by definition is unlikely to cause adverse health consequences. The defect involves a functional failure (leaking) rather than a direct safety hazard like injury or illness.
Plain-English summary
Tripath Imaging, Inc. is recalling the Manual Method 1: 480 Test Kit (PreCoat), Catalog/Model # 490529. The recall involves 46,112,784 units distributed worldwide.
The recall was initiated because the PrepStain Syringing Pipettes included in the kits may leak. This defect can prevent the pipettes from dispensing the minimum required volume of 7.5 mL of the sample. The issue has resulted in an increase in complaints regarding leaking syringing pipettes.
Affected lot codes include 100903ru, 100924rr, 101022sc, 110114sh, and 110225ru. Users should stop using the affected test kits and contact Tripath Imaging for further instructions.
The recalled product
- Product
- Manual Method 1: 480 Test Kit (PreCoat), Catalog/Model # 490529
- 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 (5)
- 100903ru
- 100924rr
- 101022sc
- 110114sh
- 110225ru
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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