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Tripath Imaging Recalls
9 recalls on record · June 27, 2012 to August 1, 2012 · Medical Devices
August 1, 2012Medical DevicesFDA
Tripath Imaging, Inc. recalls PrepStain PM Kit, T-AG (Catalog 490588); PrepStain PM Kit Europe (Catalog 490671); PrepStain Prep Only PM Kit, T-AG (Cat
Hazard: Some Prep Stain Kit, 1.2 DiTi Cones have been found to be leaking and the PrepStain Preparation kits contain incorrect preventive maintenance (PM) instructions.
August 1, 2012Medical DevicesFDA
Tripath Imaging, Inc. recalls PrepStain Slide Processor. The PrepStain System is a liquid-based thin layer cell preparation process. The PrepStain
Hazard: Some Prep Stain Kit, 1.2 DiTi Cones have been found to be leaking and the PrepStain Preparation kits contain incorrect preventive maintenance (PM) instructions.
August 1, 2012Medical DevicesFDA
Tripath Imaging, Inc. recalls PrepStain Upgrade Kit: 1.3.0.3/1.2 DiTi Cone. The PrepStain System is a liquid-based thin layer cell preparation proc
Hazard: Some Prep Stain Kit, 1.2 DiTi Cones have been found to be leaking and the PrepStain Preparation kits contain incorrect preventive maintenance (PM) instructions.
August 1, 2012Medical DevicesFDA
Tripath Imaging, Inc. recalls PrepStain Kit: 1.2 DiTi Cone. The PrepStain System is a liquid-based thin layer cell preparation process. The PrepSta
Hazard: Some Prep Stain Kit, 1.2 DiTi Cones have been found to be leaking and the PrepStain Preparation kits contain incorrect preventive maintenance (PM) instructions.
June 27, 2012Medical DevicesFDA
Tripath Imaging, Inc. recalls PrepStain GN 480 Disposable Kit Catalog/Model 490542 This is a complete kit, per the firm's explanation, that contains
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
June 27, 2012Medical DevicesFDA
Tripath Imaging, Inc. recalls Manual Method 1: 480 Test Kit (PreCoat), Catalog/Model # 490529
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
June 27, 2012Medical DevicesFDA
Tripath Imaging, Inc. recalls PrepStain Installation Kit (PreCoat), Catalog/Model # 490528
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
June 27, 2012Medical DevicesFDA
Tripath Imaging, Inc. recalls PrepStain GYN 480 Disposable Test Kit with PreCoat Slides (Catalog #490523
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
June 27, 2012Medical DevicesFDA
Tripath Imaging, Inc. recalls PrepStain Syringing Pipettes 240 (Catalog #490517)
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