BEUDAMED
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    VersaTREK Windows Software, Version 5.4.3 is a component of the VersaTrek System. The Software CD will be individually packaged using a standard CD plastic case and placed into a standard CD mailer The VersaTREK System is for cultivating and recovering microorganisms, especially bacteria and yeasts, from blood and other normally sterile body fluids.

    FDA Enforcement
    Class III ·Terminated·Trek Diagnostic Systems·September 12, 2012

    Thermo SCIENTIFIC, Sensititre CMC7AFLF, Gram Negative IVD AST

    FDA Recall
    Terminated ·Remel Inc·Product code JWY·October 20, 2022

    Thermo SCIENTIFIC, Sensititre STP6F, Gram Negative IVD AST

    FDA Recall
    Terminated ·Remel Inc·Product code JWY·October 20, 2022

    Thermo SCIENTIFIC, Sensititre GN7F, Gram Negative IVD AST

    FDA Recall
    Terminated ·Remel Inc·Product code JWY·October 20, 2022

    Thermo SCIENTIFIC, Sensititre GN6F, Gram Negative IVD AST

    FDA Recall
    Terminated ·Remel Inc·Product code JWY·October 20, 2022

    Thermo SCIENTIFIC, Sensititre HPB1, Gram Negative IVD AST

    FDA Recall
    Terminated ·Remel Inc·Product code JWY·October 20, 2022

    Thermo SCIENTIFIC, Sensititre STP7F, Gram Negative IVD AST

    FDA Recall
    Terminated ·Remel Inc·Product code JWY·October 20, 2022

    Thermo SCIENTIFIC Sensititre Plate, GN4F, Gram Negative IVD AST

    FDA Recall
    Terminated ·Remel Inc·Product code JWY·October 20, 2022

    Thermo SCIENTIFIC, Sensititre CMC5VGNF, Gram Negative IVD AST

    FDA Recall
    Terminated ·Remel Inc·Product code JWY·October 20, 2022

    Thermo SCIENTIFIC, Sensititre MDRGN3F, Gram Negative IVD AST

    FDA Recall
    Terminated ·Remel Inc·Product code JWY·October 20, 2022

    HARDY DIAGNOSTIC McFarland Standard 0.5; in vitro diagnostic, glass vial, one vial per box

    FDA Recall
    Terminated ·Trek Diagnostic Systems·Product code JTZ·September 22, 2008

    Sensititre Mueller-Hinton Broth w/Lysed Horse Blood (MHB w/LHB), Model Number: CP112-10; Lot number 150444SA. In vitro diagnostic products for clinical susceptibility testing of H. influenzae and Streptococcus spp., can provide both qualitative and quantitative results.

    FDA Recall
    Terminated ·Trek Diagnostic Systems·Product code JTZ·June 4, 2009

    VersaTREK Windows Software, Version 5.4.3 is a component of the VersaTrek System. The Software CD will be individually packaged using a standard CD plastic case and placed into a standard CD mailer The VersaTREK System is for cultivating and recovering microorganisms, especially bacteria and yeasts, from blood and other normally sterile body fluids.

    FDA Recall
    Terminated ·Trek Diagnostic Systems·Product code MDB·July 23, 2012

    VersaTREK Myco AS.

    FDA Recall
    Terminated ·Trek Diagnostic Systems·Product code MDB·August 8, 2005

    Versa TREK REDOX 2 80 ml Anaerobic blood culture bottles, Product Code: 7103-44. The product was distributed in cases containing 50 bottles per case.

    FDA Recall
    Terminated ·Trek Diagnostic Systems·Product code MDB·March 4, 2005

    Philips MR systems: Ingenia HA FLEX TRAK Trolley (for Ingenia 1.5T & 3.0T products) Product Usage: Diagnostic MR System. The Height Adjustable FlexTrak trolley and Trolley Variable Height IRF is an optional device designed to prepare the patient outside the examination room to enhance workflow and make additional non-magnetic hospital beds unnecessary.

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems, Inc.·June 25, 2014

    Philips MR systems: Trolley Variable Height IRF (for Ingenia 1.5T & 3.0T products) Product Usage: Diagnostic MR System. The Height Adjustable FlexTrak trolley and Trolley Variable Height IRF is an optional device designed to prepare the patient outside the examination room to enhance workflow and make additional non-magnetic hospital beds unnecessary.

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems, Inc.·June 25, 2014

    Philips MR systems: Ingenia HA FLEX TRAK Trolley (for Ingenia 1.5T & 3.0T products) Product Usage: Diagnostic MR System. The Height Adjustable FlexTrak trolley and Trolley Variable Height IRF is an optional device designed to prepare the patient outside the examination room to enhance workflow and make additional non-magnetic hospital beds unnecessary.

    FDA Recall
    Terminated ·Philips Medical Systems, Inc.·Product code LNH·May 15, 2014

    Philips MR systems: Trolley Variable Height IRF (for Ingenia 1.5T & 3.0T products) Product Usage: Diagnostic MR System. The Height Adjustable FlexTrak trolley and Trolley Variable Height IRF is an optional device designed to prepare the patient outside the examination room to enhance workflow and make additional non-magnetic hospital beds unnecessary.

    FDA Recall
    Terminated ·Philips Medical Systems, Inc.·Product code LNH·May 15, 2014