43 results
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12ms
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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
PrepStain Tecan US-II. For use in the screening and detection of cervical cancer.
FDA Recall
Terminated
·Becton Dickinson & Co. BD Diagnostic Systems·Product code MKQ·July 8, 2013
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 PrepStain System, Model Number: 799-14000-00; Catalog Number: 05CR000021, 05CR00021R, 799-13000-00, 799-13000-00R, 799-14000-00 and 799-14000-00R; Catalog Number: 05CR000021, 05CR000021R, 799-13000-00, 799-13000-00R, 799-14000-00 and 7914000-00R. PrepStain is a liquid-based thin layer cell preparation device for preparation and staining of Prep smear slides from cervical specimens in a liquid based format (gyn use) and of cytology examination slides from non-cervical specimens such as urine and lung lavage.
FDA Recall
Terminated
·Bd Diagnostic Systems Tripath·Product code MKQ·September 26, 2008
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 SurePathTM Preservative Collection Vials, catalog numbers 490505, 490527, 491095, 491096, and 491097. SurePath Preservative Fluid is designed for use with the PrepStain System. SurePath Preservative Fluid is an alcohol-based, preservation solution that serves as a transport, preservative and antibacterial medium for gynecologic specimens.
FDA Recall
Terminated
·Becton Dickinson & Co. 7 Loveton Cir BD Diagnostic Systems·Product code MKQ·February 12, 2016
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