33 results
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39ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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BD Focal Point"120V / 11 FOV (Refurbished), Catalog number: 490653. The BD Focal Point" Slide Profiler (formerly the AutoPap System) is an automated cervical cytology screening device intended for use in initial screening of cervical cytology slide.
FDA Recall
Terminated
·Tripath Imaging, Inc.·Product code MKQ·October 6, 2011
BD Focal Point"230V / 15 FOV under 5%, Catalog number: 490137. The BD Focal Point" Slide Profiler (formerly the AutoPap System) is an automated cervical cytology screening device intended for use in initial screening of cervical cytology slide.
FDA Recall
Terminated
·Tripath Imaging, Inc.·Product code MKQ·October 6, 2011
PrepStain Installation Kit (PreCoat), Catalog/Model # 490528
FDA Recall
Terminated
·Tripath Imaging, Inc.·Product code MKQ·March 22, 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 Recall
Terminated
·Tripath Imaging, Inc.·Product code MKQ·December 8, 2011
BD Focal Point"100V (Refurbished), Catalog number: 490651 The BD Focal Point" Slide Profiler (formerly the AutoPap System) is an automated cervical cytology screening device intended for use in initial screening of cervical cytology slide.
FDA Recall
Terminated
·Tripath Imaging, Inc.·Product code MKQ·October 6, 2011
BD Focal Point"230V / 15 FOV (Refurbished), Catalog number: 490138. The BD Focal Point" Slide Profiler (formerly the AutoPap System) is an automated cervical cytology screening device intended for use in initial screening of cervical cytology slide.
FDA Recall
Terminated
·Tripath Imaging, Inc.·Product code MKQ·October 6, 2011
BD Focal Point"230V / 11 FOV (Refurbished), Catalog number: 490649. The BD Focal Point" Slide Profiler (formerly the AutoPap System) is an automated cervical cytology screening device intended for use in initial screening of cervical cytology slide.
FDA Recall
Terminated
·Tripath Imaging, Inc.·Product code MKQ·October 6, 2011
BD Focal Point"100V / 15 FOV under 5%, Catalog number: (Refurbished) 490365 The BD Focal Point" Slide Profiler (formerly the AutoPap System) is an automated cervical cytology screening device intended for use in initial screening of cervical cytology slide.
FDA Recall
Terminated
·Tripath Imaging, Inc.·Product code MKQ·October 6, 2011
Manual Method 1: 480 Test Kit (PreCoat), Catalog/Model # 490529
FDA Recall
Terminated
·Tripath Imaging, Inc.·Product code MKQ·March 22, 2012
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 Recall
Terminated
·Tripath Imaging, Inc.·Product code MKQ·December 8, 2011
BD Focal Point"230V LC (Refurbished), Catalog number: 490681. The BD Focal Point" Slide Profiler (formerly the AutoPap System) is an automated cervical cytology screening device intended for use in initial screening of cervical cytology slide.
FDA Recall
Terminated
·Tripath Imaging, Inc.·Product code MKQ·October 6, 2011
BD Focal Point"120V LC (Refurbished), Catalog number: 490683. The BD Focal Point" Slide Profiler (formerly the AutoPap System) is an automated cervical cytology screening device intended for use in initial screening of cervical cytology slide.
FDA Recall
Terminated
·Tripath Imaging, Inc.·Product code MKQ·October 6, 2011
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 Recall
Terminated
·Tripath Imaging, Inc.·Product code MKQ·December 8, 2011
BD Focal Point"100V / 15 FOV under 5%, Catalog number: 490364 The BD Focal Point" Slide Profiler (formerly the AutoPap System) is an automated cervical cytology screening device intended for use in initial screening of cervical cytology slide.
FDA Recall
Terminated
·Tripath Imaging, Inc.·Product code MKQ·October 6, 2011
BD Focal Point"120V / 15 FOV (Refurbished), Catalog number: 490398. The BD Focal Point" Slide Profiler (formerly the AutoPap System) is an automated cervical cytology screening device intended for use in initial screening of cervical cytology slide.
FDA Recall
Terminated
·Tripath Imaging, Inc.·Product code MKQ·October 6, 2011
BD Focal Point"120v / 15 FOV under 5%, Catalog number: 490397. The BD Focal Point" Slide Profiler (formerly the AutoPap System) is an automated cervical cytology screening device intended for use in initial screening of cervical cytology slide.
FDA Recall
Terminated
·Tripath Imaging, Inc.·Product code MKQ·October 6, 2011
BD Focal Point"120V / 11 FOV under 5%, Catalog number: 490652 The BD Focal Point" Slide Profiler (formerly the AutoPap System) is an automated cervical cytology screening device intended for use in initial screening of cervical cytology slide.
FDA Recall
Terminated
·Tripath Imaging, Inc.·Product code MKQ·October 6, 2011
PrepStain GYN 480 Disposable Test Kit with PreCoat Slides (Catalog #490523
FDA Recall
Terminated
·Tripath Imaging, Inc.·Product code MKQ·March 22, 2012
BD Focal Point"100V LC (Refurbished), Catalog number: 490682 The BD Focal Point" Slide Profiler (formerly the AutoPap System) is an automated cervical cytology screening device intended for use in initial screening of cervical cytology slide.
FDA Recall
Terminated
·Tripath Imaging, Inc.·Product code MKQ·October 6, 2011
BD Focal Point"100V, Catalog number: 490650 The BD Focal Point" Slide Profiler (formerly the AutoPap System) is an automated cervical cytology screening device intended for use in initial screening of cervical cytology slide.
FDA Recall
Terminated
·Tripath Imaging, Inc.·Product code MKQ·October 6, 2011