Sunquest Information Systems

9 recalls •

• Categories: Other Medical Devices, Diagnostic Equipment

Sunquest Laboratory, version 7.0 not available

Class I - Dangerous

Sunquest is recalling Sunquest Laboratory version 7.0 because when saving an Accession to a non-current Episode/Event, a User-Defined field can be incorrectly replaced by the current Episode/Event User-Defined data.

Nov 3, 2011 Other Medical Devices Nationwide View Details →

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

Class I - Dangerous

The recall was initiated because Sunquest Information System has confirmed reports of an Outbound Phlebotomy Point of Care (POC) interface is combining patient orders inappropriately.

Nov 19, 2009 Other Medical Devices Nationwide View Details →

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

Class I - Dangerous

Online calculations may not be performed as expected or may yield results that are different than expected when the calculation module is called from the Online Entry (OEM) application for a subtest whose subcolumn number on the instrument online string is divisible by 10.

Nov 15, 2011 Other Medical Devices Nationwide View Details →

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.

Class I - Dangerous

Sunquest is recalling Sunquest Laboratory versions 6.1.0125 through 6.1.0139, 6.2.1, 6.2.2, 7.0, and 7.0.1 because when the Windows-based merge application is used and the "Event merge across patients" option is used, a receiving system (for example a HIS or CoPath system) may interpret the event merge as a full patient merge. This occurs because a trigger from the Laboratory system for the event

Mar 15, 2012 Diagnostic Equipment Nationwide View Details →

Sunquest Laboratory Versions 6.4 and later using Microbiology Result Entry

Class I - Dangerous

The recall was initiated because Sunquest has confirmed that the Sunquest Laboratory versions 6.4 and later while using Microbiology Result Entry (MRE), the specimen ribbon containing the Accession Number (AN) and the Battery Name may be missing or contain the wrong information.

Dec 5, 2011 Other Medical Devices Nationwide View Details →

Sunquest Laboratory LabAccess Results Workstation (LARS)

Class I - Dangerous

The recall was initiated because Sunquest has confirmed that the Sunquest Laboratory LabAccess Results Workstation (LARS) may file results to the wrong patient by incorrectly combining results.

Oct 5, 2010 Other Medical Devices Nationwide View Details →

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

Class I - Dangerous

In GUI inquiry, searching by ID (CID) may return the wrong patient demographic data if the accession number associated to the CID is no longer inactive.

Aug 12, 2011 Other Medical Devices Nationwide View Details →

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

Class I - Dangerous

Sunquest is recalling the Sunquest Encompass versions 2.4 and later because the specimen collect time is displaying and printing one hour later than the actual collect time only when Daylight Saving Time is active.

Apr 13, 2009 Other Medical Devices Nationwide View Details →

Sunquest Laboratory SMART & Sunquest Laboratory SMART Select

Class I - Dangerous

In Online Entry (OEx) there are two scenarios where a Test result from one container may file to a Test on another container. In order for this to occur: 1) Site parameter SIT 1,2,1,26 (3,217) [Restrict resulting of tests to owner container (<Y>/N)]=Y. 2) The Tests are ordered on the same accession number and 3) The Test codes are defined to have the same upload code as either replicate or

Apr 28, 2011 Other Medical Devices Nationwide View Details →