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41ms
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Sources: EU EUDAMED, US FDA
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PrepStain Kit: 1.2 DiTi Cone. The PrepStain System is a liquid-based thin layer cell preparation process. The PrepStain System produces SurePath Slides that are intended for use in the screening and detection of cervical cancer, pre-cancerous lesions, atypical cells and all other cytologic categories as defined by The Bethesda System for Reporting Cervical/Vaginal Cytology Diagnoses. The 1.2 DiTi is the tip on the PrepStain to which a pipette tip attaches and dispenses patient samples onto a glass microscope slide.
FDA Enforcement
Class II
·Terminated·Tripath Imaging, Inc.·August 1, 2012
PrepStain Slide Processor. The PrepStain System is a liquid-based thin layer cell preparation process. The PrepStain System produces SurePath Slides that are intended for use in the screening and detection of cervical cancer, pre-cancerous lesions, atypical cells and all other cytologic categories as defined by The Bethesda System for Reporting Cervical/Vaginal Cytology Diagnoses. The 1.2 DiTi is the tip on the PrepStain to which a pipette tip attaches and dispenses patient samples onto a glass microscope slide.
FDA Enforcement
Class II
·Terminated·Tripath Imaging, Inc.·August 1, 2012
PrepStain PM Kit, T-AG (Catalog 490588); PrepStain PM Kit Europe (Catalog 490671); PrepStain Prep Only PM Kit, T-AG (Catalog 490954); PrepStain PM Kit XLP, T-US-II (Catalog 490424); PrepStain Prep PM Kit XLP T-US-II (Catalog 491118); PrepStain Prep Only PM Kit XLP, T-US-II (490423); PrepStain Prep Only PM Kit, T-US (Catalog 490429); PrepStain PM Kit, T-US (Catalog 490626); PrepStain PM Kit Europe, T-US (Catalog 490428). The PrepStain System is a liquid-based thin layer cell preparation process. The PrepStain System produces SurePath Slides that are intended for use in the screening and detection of cervical cancer, pre-cancerous lesions, atypical cells and all other cytologic categories as defined by The Bethesda System for Reporting Cervical/Vaginal Cytology Diagnoses. The 1.2 DiTi is the tip on the PrepStain to which a pipette tip attaches and dispenses patient samples onto a glass microscope slide.
FDA Enforcement
Class II
·Terminated·Tripath Imaging, Inc.·August 1, 2012
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 System produces SurePath Slides that are intended for use in the screening and detection of cervical cancer, pre-cancerous lesions, atypical cells and all other cytologic categories as defined by The Bethesda System for Reporting Cervical/Vaginal Cytology Diagnoses. The 1.2 DiTi is the tip on the PrepStain to which a pipette tip attaches and dispenses patient samples onto a glass microscope slide.
FDA Enforcement
Class II
·Terminated·Tripath Imaging, Inc.·August 1, 2012
PrepStain GYN 480 Disposable Test Kit with PreCoat Slides (Catalog #490523
FDA Enforcement
Class III
·Terminated·Tripath Imaging, Inc.·June 27, 2012
PrepStain Installation Kit (PreCoat), Catalog/Model # 490528
FDA Enforcement
Class III
·Terminated·Tripath Imaging, Inc.·June 27, 2012
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)
FDA Enforcement
Class III
·Terminated·Tripath Imaging, Inc.·June 27, 2012
PrepStain Syringing Pipettes 240 (Catalog #490517)
FDA Enforcement
Class III
·Terminated·Tripath Imaging, Inc.·June 27, 2012
Manual Method 1: 480 Test Kit (PreCoat), Catalog/Model # 490529
FDA Enforcement
Class III
·Terminated·Tripath Imaging, Inc.·June 27, 2012