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    Nanosphere Verigene Each CDF test consists of a Verigene CDF Nucleic Acid Test Kit and a Verigene CDF Amplification Reagent Kit. The Verigene Clostridium difficile Nucleic Acid Test (CDF) is a qualitative multiplexed in vitro diagnostic test for the rapid detection of toxin A (tcdA), toxin B (tcdB), and tcdC gene sequences of toxigenic Clostridium difficile and for presumptive identification of PCR ribotype 027 strains from unformed (liquid or soft) stool specimens collected from patients suspected of having C. difficile infection (CDI). Presumptive identification of the PCR ribotype 027 strain of C. difficile is by detection of the binary toxin (cdt) gene sequence and the single base pair deletion at nucleotide 117 in the tcdC gene. The tcdC gene encodes for a negative regulator in C. difficile toxin production. The test is performed on the Verigene System and utilizes automated specimen preparation and polymerase chain reaction (PCR) amplification, combined with a nanoparticle-based array hybridization assay to detect the toxin gene sequences associated with toxin-producing C. difficile. The CDF test is indicated for use as an aid in the diagnosis of CDI. Detection of PCR ribotype 027 strains of C. difficile by the CDF test is solely for epidemiological purposes and is not intended to guide or monitor treatment for C. difficile infections. Concomitant culture is necessary only if further typing or organism recovery is required.

    FDA Recall
    Terminated ·Nanosphere, Inc.·Product code OZN·October 16, 2013

    The Verigene Clostridium difficile Nucleic Acid Test (CDF) is a qualitative, multiplexed in vitro diagnostic test for the rapid detection of toxin A (tcdA), toxin B (tcdB), and tcdC gene sequences of toxigenic strains Clostridium difficile and for presumptive identification of PCR ribotype 027 strains from unformed (liquid or soft) stool specimens collected from patients suspected of having C. difficile infection (CDI). Presumptive identification of the PCR ribotype 027 strain of C. difficile is by detection of the binary toxin (cdt) gene sequence and the single base pair deletion at nucleotide 117 in the tcdC gene. The tcdC gene encodes for a negative regulator in C. difficile toxin production. The test is performed on the Verigene System and utilizes automated specimen preparation and polymerase chain reaction (PCR) amplification, combined with a nanoparticle-based array hybridization assay to detect the toxin gene sequences associated with toxin-producing C. difficile.

    FDA Recall
    Terminated ·Nanosphere, Inc.·Product code OZN·October 10, 2013

    regard ACDF, NU00698H, Item Number 800246008; neuro surgery convenience kit

    FDA Recall
    Terminated ·ROi CPS LLC·Product code OJG·October 20, 2022

    regard ACDF, NU00698I, Item Number 800246009; neuro surgery convenience kit

    FDA Recall
    Terminated ·ROi CPS LLC·Product code OJG·October 20, 2022

    ACDF Pack, catalog #900-2917 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

    FDA Recall
    Terminated ·Customed, Inc Calle Igualdad Final # 7·Product code OJG·October 8, 2014

    Xario XG Diagnostic Ultrasound System SSA-680A Used for routine diagnostic imaging

    FDA Recall
    Terminated ·Toshiba American Medical Systems Inc·Product code IYN·August 5, 2013

    Aplio XG Diagnostic Ultrasound System SSA-790A Used for routine diagnostic imaging

    FDA Recall
    Terminated ·Toshiba American Medical Systems Inc·Product code IYN·August 5, 2013

    Aplio MX Diagnostic Ultrasound System SSA-780A Used for routine diagnostic imaging

    FDA Recall
    Terminated ·Toshiba American Medical Systems Inc·Product code IYN·August 5, 2013

    Xario Diagnostic Ultrasound System SSA-660A Used for routine diagnostic imaging

    FDA Recall
    Terminated ·Toshiba American Medical Systems Inc·Product code IYN·August 5, 2013

    Revogene RNA Software Upgrade Kit Revogene RNA Software Upgrade USBs Catalog Number: 610240 IVD used to install the Revogene System Software version 4.2.0, import the Revogene Instrument Control Protocol file for RNA-based assay, and install the Assay Definition File (ADF) file

    FDA Recall
    Terminated ·Meridian Bioscience Inc·Product code QJR·April 8, 2021

    Intermed 350 ml Sterile Water Humidifier w/5psi Adapt.

    FDA Recall
    Terminated ·Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical Company·Product code CAF·September 5, 2017

    ACE MDI Spacer with Small Mask - Product Usage: designed to assist with the delivery of aerosolized medications from metered dose inhaler canisters and with mechanically ventilated patients.

    FDA Recall
    Terminated ·Smiths Medical ASD Inc.·Product code CAF·March 31, 2021

    Sodium Chloride Inhalation Solution, USP 7%, 60 x 4 mL Sterile Unit-Dose Vials, Rx Only, NDC 0487-9007-60. A vial contains sterile, preservation-free, clear, colorless, aqueous solution as labeled for induction of sputum production where specimen collection is indicated. For respiratory therapy, Solium Chloride Inhalation Solution USP, 3% is used in conjunction with a nebulizer

    FDA Recall
    Terminated ·Nephron Pharmaceuticals Corp.·Product code CAF·November 16, 2015

    Sunset Compressor Nebulizer, Model NEB100 - Product Usage: The Sunset Compressor Nebulizer is an AC-powered air nebulizer compressor system intended to provide a source of compressed air for medical purposes for use in home healthcare. It is to be used with a nebulizer kit to produce medicated aerosol particles for respiratory therapy for both children and adults.

    FDA Recall
    Terminated ·SANRAI INTERNATIONAL LLC·Product code CAF·August 29, 2018

    The Aeroneb Professional Nebulizer System is a portable medical device for multiple patient use that is intended to aerosolize physician-prescribed solutions for inhalation to patients on and off ventilation or other positive pressure breathing assistance. The Aeroneb Professional Nebulizer System is suitable for use in adult and pediatric patients. The Aeroneb Solo Nebulizer System is an iteration of the Aeroneb Professional Nebulizer System which is single patient use. The FRIWO AC/DC adapter is a component of the Aerogen Nebulizer systems which is used to power the Pro and Pro X controllers.

    FDA Recall
    Terminated ·Aerogen Ltd. Galway Business Park Dangan Galway Ireland·Product code CAF·September 2, 2014

    Roscoe Mini Neb Compressor User Manual for the NEB-ROS Product Usage: Inhaler therapy that converts liquid medicine into a fine mist that is easily inhaled.

    FDA Recall
    Terminated ·Compass Health Brands·Product code CAF·April 20, 2015

    Medline 300-350 ml Sterile Water Humidifier w/5psi Adapt.

    FDA Recall
    Terminated ·Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical Company·Product code CAF·September 5, 2017

    Portex 1000 ml Sterile Water USP Pour Bottle

    FDA Recall
    Terminated ·Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical Company·Product code CAF·September 5, 2017

    Medline Prefilled 350 ml Sterile

    FDA Recall
    Terminated ·Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical Company·Product code CAF·September 5, 2017

    Intermed 550 ml Sterile Water Humidifier w/5psi Adapt.

    FDA Recall
    Terminated ·Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical Company·Product code CAF·September 5, 2017