Tripath Imaging, Inc.
Medical device manufacturer in Burlington, NC.
5510(k) clearances
0PMA approvals
24recalls
Device types
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K061613 | Ventana Image Analysis System - Pathway HER2 (4B5)NQN · Traditional | 01/10/2007SE |
| K062428 | Ventana Image Analysis System, Model ViasNQN · Traditional | 09/29/2006SE |
| K053520 | Ventana Image Analysis System, Model KI-67NQN · Traditional | 04/11/2006SE |
| K051282 | Ventana Image Analysis System - HER2/NEUNOT · Traditional | 08/16/2005SE |
| K050012 | Ventana Image Analysis SystemNQN · Traditional | 05/06/2005SE |
Recalls
| Recall | Product | Initiated |
|---|---|---|
| Z-1815-2012 Class III | PrepStain GN 480 Disposable Kit Catalog/Model 490542 This is a complete kit, per the…The PrepStain Syringing Pipettes may not dispense the minimum volume of 7.5 mL of the sample due to leaking.… | 03/22/2012Terminated |
| Z-1814-2012 Class III | Manual Method 1: 480 Test Kit (PreCoat), Catalog/Model # 490529The PrepStain Syringing Pipettes may not dispense the minimum volume of 7.5 mL of the sample due to leaking.… | 03/22/2012Terminated |
| Z-1813-2012 Class III | PrepStain Installation Kit (PreCoat), Catalog/Model # 490528The PrepStain Syringing Pipettes may not dispense the minimum volume of 7.5 mL of the sample due to leaking.… | 03/22/2012Terminated |
| Z-1812-2012 Class III | PrepStain GYN 480 Disposable Test Kit with PreCoat Slides (Catalog #490523The PrepStain Syringing Pipettes may not dispense the minimum volume of 7.5 mL of the sample due to leaking.… | 03/22/2012Terminated |
| Z-1811-2012 Class III | PrepStain Syringing Pipettes 240 (Catalog #490517)The PrepStain Syringing Pipettes may not dispense the minimum volume of 7.5 mL of the sample due to leaking.… | 03/22/2012Terminated |
| Z-2088-2012 Class II | PrepStain PM Kit, T-AG (Catalog 490588); PrepStain PM Kit Europe (Catalog 490671)…Some Prep Stain Kit, 1.2 DiTi Cones have been found to be leaking and the PrepStain Preparation kits contain… | 12/08/2011Terminated |
| Z-2087-2012 Class II | PrepStain Slide Processor. The PrepStain System is a liquid-based thin layer cell…Some Prep Stain Kit, 1.2 DiTi Cones have been found to be leaking and the PrepStain Preparation kits contain… | 12/08/2011Terminated |
| Z-2086-2012 Class II | PrepStain Upgrade Kit: 1.3.0.3/1.2 DiTi Cone. The PrepStain System is a liquid-based…Some Prep Stain Kit, 1.2 DiTi Cones have been found to be leaking and the PrepStain Preparation kits contain… | 12/08/2011Terminated |
| Z-2085-2012 Class II | PrepStain Kit: 1.2 DiTi Cone. The PrepStain System is a liquid-based thin layer cell…Some Prep Stain Kit, 1.2 DiTi Cones have been found to be leaking and the PrepStain Preparation kits contain… | 12/08/2011Terminated |
| Z-1643-2012 | BD Focal Point"230V LC (Refurbished), Catalog number: 490681. The BD Focal Point" Slide…The cable tie mounts that adhere to the inside of the FocalPoint do not adhere as intended and can therefore… | 10/06/2011Terminated |
| Z-1642-2012 | BD Focal Point"230V / 15 FOV (Refurbished), Catalog number: 490138. The BD Focal Point"…The cable tie mounts that adhere to the inside of the FocalPoint do not adhere as intended and can therefore… | 10/06/2011Terminated |
| Z-1641-2012 | BD Focal Point"230V / 15 FOV under 5%, Catalog number: 490137. The BD Focal Point" Slide…The cable tie mounts that adhere to the inside of the FocalPoint do not adhere as intended and can therefore… | 10/06/2011Terminated |
| Z-1640-2012 | BD Focal Point"230V / 11 FOV (Refurbished), Catalog number: 490649. The BD Focal Point"…The cable tie mounts that adhere to the inside of the FocalPoint do not adhere as intended and can therefore… | 10/06/2011Terminated |
| Z-1639-2012 | BD Focal Point"230V / 11 FOV under 5%, Catalog number: 490648. The BD Focal Point" Slide…The cable tie mounts that adhere to the inside of the FocalPoint do not adhere as intended and can therefore… | 10/06/2011Terminated |
| Z-1638-2012 | BD Focal Point"120V LC (Refurbished), Catalog number: 490683. The BD Focal Point" Slide…The cable tie mounts that adhere to the inside of the FocalPoint do not adhere as intended and can therefore… | 10/06/2011Terminated |
| Z-1637-2012 | BD Focal Point"120V / 15 FOV (Refurbished), Catalog number: 490398. The BD Focal Point"…The cable tie mounts that adhere to the inside of the FocalPoint do not adhere as intended and can therefore… | 10/06/2011Terminated |
| Z-1636-2012 | BD Focal Point"120v / 15 FOV under 5%, Catalog number: 490397. The BD Focal Point" Slide…The cable tie mounts that adhere to the inside of the FocalPoint do not adhere as intended and can therefore… | 10/06/2011Terminated |
| Z-1635-2012 | BD Focal Point"120V / 11 FOV (Refurbished), Catalog number: 490653. The BD Focal Point"…The cable tie mounts that adhere to the inside of the FocalPoint do not adhere as intended and can therefore… | 10/06/2011Terminated |
| Z-1634-2012 | BD Focal Point"120V / 11 FOV under 5%, Catalog number: 490652 The BD Focal Point" Slide…The cable tie mounts that adhere to the inside of the FocalPoint do not adhere as intended and can therefore… | 10/06/2011Terminated |
| Z-1633-2012 | BD Focal Point"100V LC (Refurbished), Catalog number: 490682 The BD Focal Point" Slide…The cable tie mounts that adhere to the inside of the FocalPoint do not adhere as intended and can therefore… | 10/06/2011Terminated |
| Z-1632-2012 | BD Focal Point"100V / 15 FOV under 5%, Catalog number: (Refurbished) 490365 The BD Focal…The cable tie mounts that adhere to the inside of the FocalPoint do not adhere as intended and can therefore… | 10/06/2011Terminated |
| Z-1631-2012 | BD Focal Point"100V / 15 FOV under 5%, Catalog number: 490364 The BD Focal Point" Slide…The cable tie mounts that adhere to the inside of the FocalPoint do not adhere as intended and can therefore… | 10/06/2011Terminated |
| Z-1630-2012 | BD Focal Point"100V (Refurbished), Catalog number: 490651 The BD Focal Point" Slide…The cable tie mounts that adhere to the inside of the FocalPoint do not adhere as intended and can therefore… | 10/06/2011Terminated |
| Z-1629-2012 | BD Focal Point"100V, Catalog number: 490650 The BD Focal Point" Slide Profiler (formerly…The cable tie mounts that adhere to the inside of the FocalPoint do not adhere as intended and can therefore… | 10/06/2011Terminated |