Tripath PrepStain GYN 480 Test Kits Recalled for Leaking Pipettes
Tripath Imaging is recalling PrepStain GYN 480 Disposable Test Kits because the syringing pipettes may leak and fail to dispense the 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 indicates the product is not likely to cause adverse health consequences. The defect involves a functional failure (leaking) that may compromise test accuracy, fitting the criteria for a moderate severity issue.
Plain-English summary
Tripath Imaging, Inc. is recalling PrepStain GYN 480 Disposable Test Kits with PreCoat Slides (Catalog #490523). The recall involves 46,112,784 units that were 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 company reported an increase in complaints regarding leaking syringing pipettes.
Healthcare providers and consumers should stop using the affected test kits. Users should check their lot numbers against the list provided in the official recall notice to determine if their products are affected.
The recalled product
- Product
- PrepStain GYN 480 Disposable Test Kit with PreCoat Slides (Catalog #490523
- 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)
- 100903ra
- 100903rb
- 100903rf
- 100903rj
- 100903rn
- 100903rr
- 100903rt
- 100903rx
- 100903sb
- 100903sc
- 100903sd
- 100903se
- 100903sf
- 100903sl
- 100910rd
- 100910re
- 100910rh
- 100910rp
- 100910rq
- 100910rr
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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