Diagnostics makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in United StatesLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field., part of Becton DickinsonLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 3 spellings of its name, each linked to the record.
As of Nov 14, 2026, FDA's public records list TriPath Imaging with 9 device recalls and 5 510(k) clearances. The most recent is a device recall dated Mar 22, 2012: PrepStain GYN 480 Disposable Test Kit with PreCoat Slides (Catalog #490523.
| Mar 22, 2012 | PrepStain GYN 480 Disposable Test Kit with PreCoat Slides (Catalog #490523Class III · The PrepStain Syringing Pipettes may not dispense the minimum volume of 7.5 mL of the sample due to leaking. This event | Device recalls |
| Mar 22, 2012 | PrepStain Syringing Pipettes 240 (Catalog #490517)Class III · The PrepStain Syringing Pipettes may not dispense the minimum volume of 7.5 mL of the sample due to leaking. This event | Device recalls |
| Mar 22, 2012 | PrepStain GN 480 Disposable Kit Catalog/Model 490542 This is a complete kit, per the firm's explanation, that contains the PrepStain SyringClass III · The PrepStain Syringing Pipettes may not dispense the minimum volume of 7.5 mL of the sample due to leaking. This event | Device recalls |
| Mar 22, 2012 | PrepStain Installation Kit (PreCoat), Catalog/Model # 490528Class III · The PrepStain Syringing Pipettes may not dispense the minimum volume of 7.5 mL of the sample due to leaking. This event | Device recalls |
| Dec 8, 2011 | PrepStain Slide Processor. The PrepStain System is a liquid-based thin layer cell preparation process. The PrepStain System produces SureClass II · Some Prep Stain Kit, 1.2 DiTi Cones have been found to be leaking and the PrepStain Preparation kits contain incorrect p | Device recalls |
| Dec 8, 2011 | PrepStain Kit: 1.2 DiTi Cone. The PrepStain System is a liquid-based thin layer cell preparation process. The PrepStain System produces SClass II · Some Prep Stain Kit, 1.2 DiTi Cones have been found to be leaking and the PrepStain Preparation kits contain incorrect p | Device recalls |
| Dec 8, 2011 | PrepStain Upgrade Kit: 1.3.0.3/1.2 DiTi Cone. The PrepStain System is a liquid-based thin layer cell preparation process. The PrepStain SClass II · Some Prep Stain Kit, 1.2 DiTi Cones have been found to be leaking and the PrepStain Preparation kits contain incorrect p | Device recalls |
| Dec 8, 2011 | PrepStain PM Kit, T-AG (Catalog 490588); PrepStain PM Kit Europe (Catalog 490671); PrepStain Prep Only PM Kit, T-AG (Catalog 490954); PrepStClass II · Some Prep Stain Kit, 1.2 DiTi Cones have been found to be leaking and the PrepStain Preparation kits contain incorrect p | Device recalls |
| Jan 10, 2007 | VENTANA IMAGE ANALYSIS SYSTEM - PATHWAY HER2 (4B5)K061613 · NQN | 510(k) clearances |
| Sep 29, 2006 | VENTANA IMAGE ANALYSIS SYSTEM, MODEL VIASK062428 · NQN | 510(k) clearances |
| Apr 11, 2006 | VENTANA IMAGE ANALYSIS SYSTEM, MODEL KI-67K053520 · NQN | 510(k) clearances |
| Aug 16, 2005 | VENTANA IMAGE ANALYSIS SYSTEM - HER2/NEUK051282 · NOT | 510(k) clearances |
| May 6, 2005 | VENTANA IMAGE ANALYSIS SYSTEMK050012 · NQN | 510(k) clearances |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
