BEUDAMED
    20 results · 95ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

    Sunquest Laboratory, version 7.0 not available

    FDA Recall
    Terminated ·Sunquest Information Systems, Inc.·Product code JQP·November 3, 2011

    Sunquest Encompass The reporting site is using the Encompass software in an acute patient care setting.

    FDA Recall
    Terminated ·Sunquest Information Systems, Inc.·Product code JQP·April 13, 2009

    Sunquest Laboratory SMART & Sunquest Laboratory SMART Select Product Usage: for clinical use

    FDA Recall
    Terminated ·Sunquest Information Systems, Inc.·Product code JQP·August 12, 2011

    Sunquest Laboratory versions 5.3, 5.4, 6.1, 6.2 and 6.3. Sunquest Laboratory Information System is comprised of several modules which are involved in aspects such as blood banking, collection management, specimen tracking, and use with microbiology and molecular diagnostics. Key capabilities include: 1) Autoverify results directly from analyzers and reference laboratories 2) Track tubes and containers from order to final disposition 3) Monitor key metrics such as turnaround time and utilization using management reports 4) Produce pathology results with Structured Reports 5) Suggest microbiology workups online according to defined SOPs and rules 6) All data entered into the system is accessible through audit trails and Ad Hoc Report tools 7) Any change to patient results (inquiry, reports) is logged and available for review

    FDA Recall
    Terminated ·Sunquest Information Systems, Inc.·Product code JQP·April 17, 2008

    Sunquest Laboratory SMART & Sunquest Laboratory SMART Select

    FDA Recall
    Terminated ·Sunquest Information Systems, Inc.·Product code JQP·April 28, 2011

    Sunquest Laboratory LabAccess Results Workstation (LARS)

    FDA Recall
    Terminated ·Sunquest Information Systems, Inc.·Product code JQP·October 5, 2010

    Sunquest Laboratory Versions 6.4 and later using Microbiology Result Entry

    FDA Recall
    Terminated ·Sunquest Information Systems, Inc.·Product code JQP·December 5, 2011

    Sunquest Application Interfacing Outbound Phlebotomy Point of Care Interface, v3.0.0_07222004 and later.

    FDA Recall
    Terminated ·Sunquest Information Systems, Inc.·Product code JQP·November 19, 2009

    Sunquest Laboratory System. Software Version: Sunquest Laboratory v5.4.2, v6.1, v6.2 and v6.3. The system is marketed as an automated solution for managing laboratory processes including: 1) Patient registration, 2) Order entry and order modification, 3) Specimen collection, verification, suitability, and distribution, 4) Quality assurance checking, 5) Workload recording, 6) Billing charge capture, 7) Standards and controls recording, 8) Test order result inquiry and reporting, 9) Organism susceptibility and epidemiology records, 10) Microbiology culture direct examination and observation recording, 11) Outreach clients, specimens, and results, 12) Client-specific reporting capabilities, 13) Inbound client service request tracking, and 14) Historical data.

    FDA Recall
    Terminated ·Sunquest Information Systems, Inc.·Product code JQP·August 1, 2008

    Sunquest Laboratory Sunquest Laboratory is intended for use by professionals working in a clinical laboratory. Sunquest Laboratory is intended for use only by professionals who have received extensive training in the use of the software. Sunquest Laboratory is controlled via userdefined security levels, which allow the laboratories to manage data security and integrity. The system is marketed as an automated solution for managing laboratory processes, including: " Patient registration " Order entry and order modification " Specimen collection, verification, suitability, and distribution " Quality assurance checking " Workload recording " Billing charge capture " Standards and controls recording " Test order result inquiry and reporting Organism susceptibility and epidemiology records " Microbiology culture direct examination and observation recording " Outreach clients, specimens, and results " Client-specific reporting capabilities " Inbound client service request tracking " Historical data Clients that use the Sunquest Blood Bank system should refer to the intended use statement found in the Blood Bank System Overview Users Guide.

    FDA Recall
    Terminated ·Sunquest Information Systems, Inc.·Product code JQP·March 15, 2012

    Sunquest Laboratory : intended for use by professionals working in a clinical laboratory.

    FDA Recall
    Terminated ·Sunquest Information Systems, Inc.·Product code JQP·November 15, 2011

    Sunquest Laboratory, version 7.0 not available

    FDA Enforcement
    Class II ·Terminated·Sunquest Information Systems, Inc.·November 14, 2012

    Sunquest Application Interfacing Outbound Phlebotomy Point of Care Interface, v3.0.0_07222004 and later.

    FDA Enforcement
    Class II ·Terminated·Sunquest Information Systems, Inc.·November 14, 2012

    Sunquest Laboratory SMART & Sunquest Laboratory SMART Select

    FDA Enforcement
    Class III ·Terminated·Sunquest Information Systems, Inc.·August 22, 2012

    Sunquest Laboratory Versions 6.4 and later using Microbiology Result Entry

    FDA Enforcement
    Class II ·Terminated·Sunquest Information Systems, Inc.·September 5, 2012

    Sunquest Laboratory Sunquest Laboratory is intended for use by professionals working in a clinical laboratory. Sunquest Laboratory is intended for use only by professionals who have received extensive training in the use of the software. Sunquest Laboratory is controlled via userdefined security levels, which allow the laboratories to manage data security and integrity. The system is marketed as an automated solution for managing laboratory processes, including: " Patient registration " Order entry and order modification " Specimen collection, verification, suitability, and distribution " Quality assurance checking " Workload recording " Billing charge capture " Standards and controls recording " Test order result inquiry and reporting Organism susceptibility and epidemiology records " Microbiology culture direct examination and observation recording " Outreach clients, specimens, and results " Client-specific reporting capabilities " Inbound client service request tracking " Historical data Clients that use the Sunquest Blood Bank system should refer to the intended use statement found in the Blood Bank System Overview Users Guide.

    FDA Enforcement
    Class II ·Terminated·Sunquest Information Systems, Inc.·September 19, 2012

    Sunquest Encompass The reporting site is using the Encompass software in an acute patient care setting.

    FDA Enforcement
    Class III ·Terminated·Sunquest Information Systems, Inc.·August 29, 2012

    Sunquest Laboratory : intended for use by professionals working in a clinical laboratory.

    FDA Enforcement
    Class III ·Terminated·Sunquest Information Systems, Inc.·October 24, 2012

    Sunquest Laboratory LabAccess Results Workstation (LARS)

    FDA Enforcement
    Class II ·Terminated·Sunquest Information Systems, Inc.·September 5, 2012

    Sunquest Laboratory SMART & Sunquest Laboratory SMART Select Product Usage: for clinical use

    FDA Enforcement
    Class III ·Terminated·Sunquest Information Systems, Inc.·August 29, 2012