9 results
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60ms
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Sources: EU EUDAMED, US FDA
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FDA Enforcement
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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