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    SimpliRED D-Dimer, Product Code DSRK4 The SimpliRED D-dimer assay is a rapid, qualitative test for the detection of cross-linked fibrin degradation products containing the cross-linked D-diner site in human whole blood

    FDA Enforcement
    Class II ·Terminated·BBI SOLUTIONS OEM LTD·November 2, 2016

    Perceval Dual Collapser, Size S/M, REF: ICV1235, Sterile EO, Rx Only, CE, UDI: 08022057014832 - Product Usage: he Dual Collapser is a component of the Perceval single use accessory kits used to reduce the Perceval Sutureless heart valve diameter before valve implant, allowing the Perceval implantation.

    FDA Recall
    Terminated ·Sorin Group Italia S.r.l. Via Crescentino Sn Saluggia Italy·Product code LWR·July 29, 2020

    Perceval Single Use Accessory Kit, Size M, REF: ICV1350, Sterile EO, Rx Only, CE, UDI: 8022057015259 - Product Usage: he Dual Collapser is a component of the Perceval single use accessory kits used to reduce the Perceval Sutureless heart valve diameter before valve implant, allowing the Perceval implantation.

    FDA Recall
    Terminated ·Sorin Group Italia S.r.l. Via Crescentino Sn Saluggia Italy·Product code LWR·July 29, 2020

    Perceval Single Use Accessory Kit, Size S, REF: ICV1345, Sterile EO, Rx Only, CE, UDI: 8022057015204 - Product Usage: he Dual Collapser is a component of the Perceval single use accessory kits used to reduce the Perceval Sutureless heart valve diameter before valve implant, allowing the Perceval implantation.

    FDA Recall
    Terminated ·Sorin Group Italia S.r.l. Via Crescentino Sn Saluggia Italy·Product code LWR·July 29, 2020

    Perceval Single Use Accessory Kit, Size S, REF: ICV1349, Sterile EO, Rx Only, CE, UDI: 8022057015211 - Product Usage: he Dual Collapser is a component of the Perceval single use accessory kits used to reduce the Perceval Sutureless heart valve diameter before valve implant, allowing the Perceval implantation.

    FDA Recall
    Terminated ·Sorin Group Italia S.r.l. Via Crescentino Sn Saluggia Italy·Product code LWR·July 29, 2020

    Perceval Single Use Accessory Kit, Size M, REF: ICV1346, Sterile EO, Rx Only, CE, UDI: 8022057015228 - Product Usage: he Dual Collapser is a component of the Perceval single use accessory kits used to reduce the Perceval Sutureless heart valve diameter before valve implant, allowing the Perceval implantation.

    FDA Recall
    Terminated ·Sorin Group Italia S.r.l. Via Crescentino Sn Saluggia Italy·Product code LWR·July 29, 2020

    Tina-quant Complement C4 ver.2, Catalog 05991994190

    FDA Recall
    Terminated ·Roche Diagnostics Operations, Inc.·Product code DBI·August 27, 2020

    HUDSON RCI SHERIDAN SHERI-BRONCH Endobronchial Tube REF 5-16135 - Product Usage: The Sheridan Endobronchial Tubes are intended for use in Thoracic surgery, brochospirometry, adminitration of endobronchial anesthesia and other uses commonly requiring endobronchial intubation. The Sheridan Endobronchial tube is indicated for main stem bronchus intubation and allows for selective inflation or deflation of either lung.

    FDA Recall
    Terminated ·Teleflex Medical·Product code CBI·October 30, 2019

    HUDSON RCI, Sheridan SHER-I BRONCH Accessory Pack, Rx Only, Sterile. Used to aspirate liquids or semisolids from a patient's upper airway.

    FDA Recall
    Terminated ·Teleflex Medical·Product code CBI·June 1, 2015

    Parker Left Double Lumen Endobronchial Tube with Parker Flex-Tip (Parker Endo-Bronch with Flex Tip). Model Numbers: H-PFTDL-28-1, H-PFTDL-32-1, H-PFTDL-35-1, H-PFTDL-37-1, H-PFTDL-39-1, H-PFTDL-41-1. The product is an endotracheal tube with a double lumen for single lung isolation allowing for ventilation of one lung during a surgical procedure. Endotracheal tubes are used for intubating patients and used in conjunction with a ventilator to provide oxygen and anesthetic agents to the patient during surgeries

    FDA Recall
    Terminated ·Parker Medical·Product code CBI·December 16, 2016

    HUDSON RCI, Sheridan, SHER-I-SWIV and SHER-I-SWIV/FO Double Swivel, Rx Only, Sterile. Used temporarily to make rigid a flexible tracheal tube to aid its insertion into a patient.

    FDA Recall
    Terminated ·Teleflex Medical·Product code CBI·June 1, 2015

    Sheridan Sher-I-Bronch Left Endobronchial Tube; an Rx, sterile, sinlge use endobronchial tube with modified tip for left bronchial intubation, 37 Fr.; Hudson Respiratory Care Inc., Temecula, CA 92589-9020, Manufactured in Mexico; sold under the following catalog numbers: a) catalog number (REF) V5-16037: Novaplus Sterile Sher-I-Bronch Endobronchial Tube for Left Bronchial Intubation, 37 Fr., Novation Corporation, Irving, TX 75062 b) catalog number (REF) 5-16037: Hudson RCI Sheridan Sher-I-Bronch Endobronchial Tube for Left Bronchial Intubation, 37 Fr.

    FDA Recall
    Terminated ·Teleflex Medical·Product code CBI·February 23, 2005

    Sheridan Sher-I-Bronch Endobronchial Tube for Right Bronchial Intubation; an Rx, sterile, sinlge use endobronchial tube with modified tip for right bronchial intubation, 37 Fr.; Hudson Respiratory Care Inc., Temecula, CA 92589-9020, Manufactured in Mexico; catalog number (REF) 5-16137

    FDA Recall
    Terminated ·Teleflex Medical·Product code CBI·February 23, 2005

    HUDSON RCI, Sheridan Sher-I-BRONCH, Endobronchial Tube (Right sided), Sizes: 28 Fr., 35 Fr., 37 Fr., 39 Fr. and 41 Fr., Rx Only, Sterile. Intended for use in thoracic surgery, bronchospirometry, for the administration of bronchial anesthesia and other uses commonly requiring bronchial intubation.

    FDA Recall
    Terminated ·Teleflex Medical·Product code CBI·June 1, 2015

    C4 is an in vitro diagnostic assay for the quantitative determination of C4 in human serum or plasma. Antigen in the sample bonds to the specific antibody in the reagent, forming an immune complex. The immune complex causes an increase in light scattering, measured by reading turbidity at 604 nm, which correlates with the concentration of C4 in the sample.

    FDA Recall
    Terminated ·Abbott Laboratories, Inc·Product code DBI·May 16, 2018

    HUDSON RCI, Sheridan Sher-I-BRONCH, Endobronchial Tube (Left sided), Sizes: 28 Fr., 35 Fr., 37 Fr., 39 Fr. and 41 Fr., Rx Only, Sterile. Intended for use in thoracic surgery, bronchospirometry, for the administration of bronchial anesthesia and other uses commonly requiring bronchial intubation.

    FDA Recall
    Terminated ·Teleflex Medical·Product code CBI·June 1, 2015

    Product: ABL800 FLEX with Crea. The ABL800 with Crea is available in the following configurations: ABL817, ABL827 and ABL837. ABL800 Series Ref. 393-803, 393-804, 393-805, 393-806, 393-820, 393-821, 393-825, 393-826, 393-835, 393-836, 393-844, 393-845.

    FDA Recall
    Terminated ·Radiometer America Inc·Product code CHL·July 2, 2018

    SimpliRED D-Dimer, Product Code DSRK4 The SimpliRED D-dimer assay is a rapid, qualitative test for the detection of cross-linked fibrin degradation products containing the cross-linked D-diner site in human whole blood

    FDA Recall
    Terminated ·BBI SOLUTIONS OEM LTD 8 Tom McDonald Avenue Dundee United Kingdom·Product code GHH·June 1, 2016

    HER2 Image Analysis Manual Read of HER2 Digital Slides ER/PR Image Analysis IHC PR Breast Tissue Manual Read of Digital Slides The ScanScope System is an automated digital slide creation, management, viewing and analysis system. It is intended for in vitro diagnostic use as an aid to the pathologist in the display, detection, counting and classification of tissues and cells of clinical interest based on particular color, intensity, size, pattern and shape. The IHC HER2 Image Analysis application is intended for use as an aid to the pathologist in the detection and semi-quantitative measurement of HER2/neu (c-erbB-2) in formalin-fixed, paraffin-embedded normal and neoplastic tissue. The IHC HER2 Image Analysis application is intended for use as an accessory to the Dako HercepTest" to aid in the detection and semi-quantitative measurement of Her2/neu (c-erbB-2) in formalin-fixed, paraffin-embedded normal and neoplastic tissue. When used with the Dako HercepTest", it is indicated for use as an aid in the assessment of breast cancer patients for whom HERCEPTIN(Trastuzumab) treatment is being considered. Note: The IHC HER2 Image Analysis application is an adjunctive computer-assisted methodology to assist the reproducibility of a qualified pathologist in the acquisition and measurement of images from microscope slides of breast cancer specimens stained for the presence of HER-2 receptor protein. The accuracy of the test result depends upon the quality of the immunohistochemical staining. It is the responsibility of a qualified pathologist to employ appropriate morphological studies and controls as specified in the instructions for the Dako HercepTest" to assure the validity of the IHC HER2 Image Analysis application assisted HER-2/neu score. The actual correlation of the Dako HercepTest" to Herceptin clinical outcome has not been established. Manual Read of HER2 Digital Slides: The ScanScope System is an automated digital slide creation, management, viewing and analysis system. It is intended for in vitro diagnostic use as an aid to the pathologist in the display, detection, counting and classification of tissues and cells of clinical interest based on particular color, intensity, size, pattern and shape. The IHC HER2 Manual Read of Digital Slides application is intended for use as an aid to the pathologist in the detection and semi-quantitative measurement of HER-2/neu (c-erbB-2) by manual examination of the digital slide of formalin-fixed, paraffin-embedded normal and neoplastic tissue immunohistochemically stained for HER-2 receptors on a computer monitor. HER-2 results are indicated for use as an aid in the management, prognosis and prediction of therapy outcomes of breast cancer. The IHC HER2 Manual Read of Digital Slides application is intended for use as an accessory to the Dako HercepTestT to aid the pathologist in the detection and semi-quantitative measurement of HER-2/neu (c-erbB-2) by manual examination of the digital slide of formalin-fixed, paraffin-embedded normal and neoplastic tissue immunohistochemically stained for HER-2 receptors on a computer monitor. When used with the Dako HercepTestT, it is indicated for use as an aid in the assessment of breast cancer patients for whom HERCEPTIN (Trastuzumab) treatment is being considered. Note: The actual correlation of the Dako HercepTestT to Herceptin clinical outcome has not been established. ER/PR Image Analysis: The ScanScope XT System is an automated digital slide creation, management, viewing and analysis system. It is intended for in vitro diagnostic use as an aid to the pathologist in the display, detection, counting and classification of tissues and cells of clinical interest based on particular color, intensity, size, pattern and shape. The IHC ER Image Analysis application is intended for use as an aid to the pathologist in the detection and quantitative measurement of ER (Estrogen Receptor) in formalin-fixed paraffin-embedded normal and neo

    FDA Recall
    Terminated ·Leica Biosystems Imaging, Inc.·Product code NOT·February 7, 2014