BEUDAMED
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    FLEXIBLE NEURO-FIBERSCOPE, 3.7MM X 34CM, Model # 11282BN1

    FDA Recall
    Terminated ·Karl Storz Endoscopy·Product code GWG·February 20, 2019

    Artis Q/ Q zen systems; Artis Q/ Q zen systems are dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. Procedures that can be performed include cardiac angiography, neuro angiography, general angiography, rotational angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures.

    FDA Recall
    Terminated ·Siemens Medical Solutions USA, Inc·Product code OWB·March 19, 2015

    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

    AxSYM CMV IgM Reagent Pack; list 05C78; 100 test pack; in-vitro diagnostic; Abbott Laboratories, Abbott Park, IL 60064

    FDA Recall
    Terminated ·Abbott Laboratories·Product code LKQ·April 23, 2007

    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

    Dialysate Concentrate for Hemodialysis-Liquid/Powd - Product Usage: used in conjunction with bicarbonate in a compatible artificial kidney (hemodialysis) machine.

    FDA Recall
    Terminated ·Medivators, Inc.·Product code FKQ·April 20, 2021

    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

    IMMULITE 2000/IMMULITE 2000XPi Systems CMM CMV IgM Assay, REF/Catalog Number L2KCM2(D) - 200 tests (US), SMN 10370302 (US), UDI 00630414985725 (US); and REF/Catalog Number L2KCM2 - 200 tests (OUS), SMN 10371320 (OUS), UDI 00630414961163 (OUS); IVD --- Siemens Healthcare Diagnostics Products Ltd., Llanberis, Gwynedd, LL55 4EL UK For in vitro diagnostic use with IMMULITE 2000 analyzers for the qualitative detection of IgM antibodies to cytomegalovirus (CMV) in human serum or plasma (EDTA or heparinized), as an aid in the diagnosis of current and recent CMV infection in individuals with signs and symptoms of CMV infection or clinical suspicion of CMV infection. This assay is not FDA cleared or approved for use in testing (screening) blood or plasma donors, neonatal screening, or for use at point-of-care facilities.

    FDA Recall
    Terminated ·Siemens Healthcare Diagnostics, Inc.·Product code LKQ·August 30, 2016

    QIAGEN artus CMV RG PCR ASR (24) (Catalog number 4503223) Product Usage: The artus CMV RG PCR ASR is designed to detect and to quantify nucleic acid specific to human cytomegalovirus (CMV) using real-time PCR technology (PCR) in the Rotor-Gene 2000/3000 (RG).

    FDA Recall
    Terminated ·QIAGEN Gaithersburg, Inc.·Product code LKQ·January 30, 2013

    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

    QIAGEN artus CMV RG PCR ASR (96) (Catalog number 4503225) Product Usage: Test is intended for use in the detection and quantitation of human cytomegalovirus (CMV) specific DNA, as part of an in house validated real-time PCR assay. One service package containing the handbook.

    FDA Recall
    Terminated ·QIAGEN Gaithersburg, Inc.·Product code LKQ·January 30, 2013