Tripath PrepStain Syringing Pipettes Recalled for Leaking Defect
Tripath Imaging is recalling PrepStain Syringing Pipettes because they may leak and fail to dispense the minimum required volume of 7.5 mL.
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 is a functional failure (leaking) rather than a direct safety hazard like contamination or injury.
Plain-English summary
Tripath Imaging, Inc. is recalling PrepStain Syringing Pipettes 240, which are included in the PrepStain GN 480 Disposable Kit (Catalog/Model 490542). The recall covers 46,112,784 units distributed worldwide.
The recall was initiated because the syringing pipettes may leak, which can prevent them from dispensing the minimum volume of 7.5 mL of the sample. This defect has resulted in an increase in complaints regarding leaking pipettes.
The affected lots are listed under the PrepStain Syringing Pipettes 240 component. Users should check their inventory for the specific lot numbers identified in the recall notice and contact the manufacturer for further instructions.
The recalled product
- Product
- PrepStain GN 480 Disposable Kit Catalog/Model 490542 This is a complete kit, per the firm's explanation, that contains the PrepStain Syringing Pipettes 240, the product being recalled. The affected lots are listed under those pipettes (PrepStain Syringing Pipettes 240)
- 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)
- This is a complete kit
- per the firm's explanation
- that contains the PrepStain Syringing Pipettes 240
- which are: 100901a
- 100902f
- 100903d
- 100908c
- 100910c
- 100914f
- 100916d
- 100921d
- 100928c
- 101005a
- 101007d
- 101008c
- 101012c
- 101013a
- 101015c
- 101020d
- 101022c
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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