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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 Enforcement
    Class III ·Terminated·Nanosphere, Inc.·August 20, 2014

    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 Enforcement
    Class II ·Terminated·Meridian Bioscience Inc·May 19, 2021

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

    FDA Enforcement
    Class II ·Terminated·Toshiba American Medical Systems Inc·November 6, 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 Enforcement
    Class II ·Terminated·Nanosphere, Inc.·October 1, 2014

    Drop Arm Versamode"

    FDA Enforcement
    Class II ·Terminated·Gf Health Products·April 14, 2021

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

    FDA Enforcement
    Class II ·Terminated·Toshiba American Medical Systems Inc·November 6, 2013

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

    FDA Enforcement
    Class II ·Terminated·Toshiba American Medical Systems Inc·November 6, 2013

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

    FDA Enforcement
    Class II ·Terminated·Toshiba American Medical Systems Inc·November 6, 2013

    Lumex, Patriot Full Electric Homecare Bed, & Patriot LX Full Electric Homecare Bed containing the Okin Dumat 3 Head/Foot Motors. Description Part Number Motor and Pendant Patriot Full Electric 120V 690-3001-943 / 690-7001-943 Boxed Full Electric 220V Motor 690-3220-943 Motor and Pendant Patriot LX Full Electric 120V 690-8004-912

    FDA Enforcement
    Class II ·Terminated·GF Health Products, Inc·December 21, 2016

    Zenith Slide W-I-D-E Long Term Care Bed, Model(s) APS98674, APS9867406, APS986741, APS986742, ZG58674, ZG78674, ZZ78674, ZZ98674, and ZZ98774. Designed for use within an institutional healthcare environment (i.e. assisted living, skilled nursing, transitional care, rehabilitation centers, etc.).

    FDA Enforcement
    Class II ·Terminated·GF Health Products, Inc./d.b.a.Basic American Metal Products·September 24, 2014