FDA-Device2012-06-27Class III

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)

Tripath Imaging, Inc.
Hazard

The PrepStain Syringing Pipettes may not dispense the minimum volume of 7.5 mL of the sample due to leaking. This event resulted in an increase in complaints of leaking syringing pipettes

Sold states
Worldwide Distribution.
Affected count
46,112,784 for all products in Recall Event
Manufactured in
780 Plantation Dr, N/A, Burlington, NC, United States
Products
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)

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1815-2012

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