BEUDAMED
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    Accu-Chek Inform II Base Unit as a part of the Accu-Chek Inform II Blood Glucose Monitoring System Accu-Chek inform II Blood Glucose Monitoring System is intended for testing outside the body (in vitro diagnostic use) and is intended for multiple-patient use in professional healthcare settings. This system should only be use with single-use, auto-disabling lancing devices.

    FDA Enforcement
    Class II ·Terminated·Roche Diagnostics Operations, Inc.·March 23, 2016

    ACCU-CHEK Inform II Blood Glucose Monitoring System bar code scanner. Used with the ACCU-CHEK Inform II System to quantitatively measure glucose (sugar).

    FDA Enforcement
    Class II ·Terminated·Roche Diagnostics Operations, Inc.·April 24, 2013

    Accu-Chek Inform II Test Strip, Whole blood glucose test system, Catalog no. 05942861001 Product Usage: The Accu-Chek Inform II test strips are for use with the Accu-Chek Inform II meter to quantitatively measure glucose (sugar) in venous whole blood, arterial whole blood, neonatal heel stick, or fresh capillary whole blood samples drawn from the fingertips as an aid in monitoring the effectiveness of glucose control. The system is not for use in diagnosis or screening of diabetes mellitus, nor for testing neonate cord blood samples.

    FDA Enforcement
    Class II ·Terminated·Roche Diabetes Care, Inc.·June 20, 2018

    Siemens EasyLink Informatics System V4.0/V5 Siemens, Material Number (SMN) 10444799, 10444800, 10487219 A clinical data management system that assists medical laboratory professionals with preanalytic and post-analytic functions in conjunction with multiple instruments, the laboratory information system (LIS) and Siemens StreamLAB Automation Solutions.

    FDA Enforcement
    Class II ·Terminated·Siemens Healthcare Diagnostics, Inc.·September 10, 2014

    EasyLink(TM) Informatics System, Part Number 1000034805. EasyLink(TM) Informatics System is classified as a data calculator and processing module for use with In-Vitro diagnostics devices.

    FDA Enforcement
    Class II ·Terminated·Siemens Healthcare Diagnostics, Inc.·August 15, 2012

    ACCU-CHEK Inform II Blood Glucose Monitoring System bar code scanner. Used with the ACCU-CHEK Inform II System to quantitatively measure glucose (sugar).

    FDA Recall
    Terminated ·Roche Diagnostics Operations, Inc.·Product code NBW·March 6, 2013

    EasyLink(TM) Informatics System, Part Number 1000034805. EasyLink(TM) Informatics System is classified as a data calculator and processing module for use with In-Vitro diagnostics devices.

    FDA Recall
    Terminated ·Siemens Healthcare Diagnostics, Inc.·Product code NSX·June 7, 2012

    EasyLink Informatic System is included with the Dimension Vista System. The Dimension Vista Integrated System is an in vitro diagnostic device intended tot duplicate manual analytical procedures such as pipetting, mixing, heating, and measuring spectral intensities to determine a variety of analytes in human body fluids. The EasyLink Informatics System is classified as a data calculator and processing module for use with in vitro diagnostic devices. The EasyLink is included with the Dimension Vista System and may be used with other Siemens analyzers as a communications and connectivity workstation for integration with laboratory information system (LIS) networks.

    FDA Enforcement
    Class II ·Terminated·Siemens Healthcare Diagnostics, Inc.·August 29, 2012

    Accu-Chek Inform II Base Unit as a part of the Accu-Chek Inform II Blood Glucose Monitoring System Accu-Chek inform II Blood Glucose Monitoring System is intended for testing outside the body (in vitro diagnostic use) and is intended for multiple-patient use in professional healthcare settings. This system should only be use with single-use, auto-disabling lancing devices.

    FDA Recall
    Terminated ·Roche Diagnostics Operations, Inc.·Product code LFR·February 11, 2016

    BD Synapsys Microbiology Informatics Solution, Catalog Number 444150, Software Version 4.10

    FDA Enforcement
    Class II ·Terminated·Becton Dickinson & Co.·May 11, 2022

    BD Synapsys Microbiology Informatics Solution, Catalog Number 444150, Software Version 4.10

    FDA Recall
    Terminated ·Becton Dickinson & Co.·Product code JQP·March 9, 2022

    Accu-Chek Inform II Test Strip, Whole blood glucose test system, Catalog no. 05942861001 Product Usage: The Accu-Chek Inform II test strips are for use with the Accu-Chek Inform II meter to quantitatively measure glucose (sugar) in venous whole blood, arterial whole blood, neonatal heel stick, or fresh capillary whole blood samples drawn from the fingertips as an aid in monitoring the effectiveness of glucose control. The system is not for use in diagnosis or screening of diabetes mellitus, nor for testing neonate cord blood samples.

    FDA Recall
    Terminated ·Roche Diabetes Care, Inc.·Product code LFR·May 7, 2018

    EasyLink Informatics System, software version 3.0, Part Number 1000034941, DADE BEHRING INC., Newark, DE.

    FDA Recall
    Terminated ·Dade Behring, Inc.·Product code JJE·July 3, 2007

    EasyLink Informatics Systems QCFIRST Custom Rule The EasyLink Informatics System is classified as a data calculator and processing module for use with In-vitro diagnostic devices. The EasyLink is included with the Dimension Vista System (K051087), and may be used with other Siemens analyzers, as a communications and connectivity workstation for integration with laboratory information system (LIS) networks.

    FDA Recall
    Terminated ·Siemens Healthcare Diagnostics, Inc.·Product code JJE·July 23, 2010

    CoaguChek XS Pro meters (catalog number 05530199160)bar code scanner. Used with the CoagCHEK XS Pro Meters to quantitatively determines prothrombin time ("PT").

    FDA Enforcement
    Class II ·Terminated·Roche Diagnostics Operations, Inc.·April 24, 2013

    iSite PACS image management system; Picture Archiving and Communications System; Radiology software package, Philips Healthcare Informatics, Foster City, CA 94404.

    FDA Recall
    Terminated ·Philips Healthcare Informatics, Inc.·Product code LLZ·January 4, 2008

    Vital Sync RMS 1.0 when loaded with v2.4 software, packaged on a CD or other electronically controlled device. CDs are packaged in clam shell jeweled cases within a carton box. The Vital Sync Virtual Patient Monitoring Platform is intended to be used by healthcare professionals for the following purposes: 1) To remotely consult regarding a patients status; and 2) To remotely review near real-time patient data, waveforms and alarms in order to utilize this information to aid in clinical decisions and deliver patient care in a timely manner.

    FDA Enforcement
    Class II ·Terminated·Nellcor Puritan Bennett Inc. (dba Covidien LP)·August 20, 2014

    Vital Sync" VPMP & IM, software, V2.4. (DVD), packaged on a CD or other electronically controlled device. CDs are packaged in clam shell jeweled cases within a carton box. The Vital Sync Virtual Patient Monitoring Platform is intended to be used by healthcare professionals for the following purposes: 1) To remotely consult regarding a patients status; and 2) To remotely review near real-time patient data, waveforms and alarms in order to utilize this information to aid in clinical decisions and deliver patient care in a timely manner.

    FDA Enforcement
    Class II ·Terminated·Nellcor Puritan Bennett Inc. (dba Covidien LP)·August 20, 2014

    EasyLink(TM) Informatics Systems Software Version 5.0 and Software Version 5.0 Service Packs 1 through 4 used with the Dimension Vista(R) System. The EasyLink(TM) Informatics System is classified as a data calculator and processing module for use with In-vitro diagnostics devices. The EasyLink(TM) is included with the Dimension Vista(R) System, and may be used with other Siemens analyzers, as a communications and connectivity workstation for integration with laboratory information system (LIS) networks. Product Quantity Distributed (Int) 787

    FDA Recall
    Terminated ·Siemens Healthcare Diagnostics, Inc.·Product code JJE·December 2, 2011

    EasyLink Informatic System is included with the Dimension Vista System. The Dimension Vista Integrated System is an in vitro diagnostic device intended tot duplicate manual analytical procedures such as pipetting, mixing, heating, and measuring spectral intensities to determine a variety of analytes in human body fluids. The EasyLink Informatics System is classified as a data calculator and processing module for use with in vitro diagnostic devices. The EasyLink is included with the Dimension Vista System and may be used with other Siemens analyzers as a communications and connectivity workstation for integration with laboratory information system (LIS) networks.

    FDA Recall
    Terminated ·Siemens Healthcare Diagnostics, Inc.·Product code JQP·May 29, 2012