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U.S. Department of Health and Human Services

Enforcement Report - Week of September 19, 2012

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Product Detail

Product Description 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.
Recall Number Z-2332-2012
Classification Class II
Code Info Version versions 6.1.0125 through 6.1.0139, 6.2.1, 6.2.2, 7.0, and 7.0.1
Product Distributed Qty 126 sites
Reason For Recall 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 merge across patients may be formatted exactly the same as the patient-to-patient merge trigger. This may also occur if the application interfacing code has not been modified to process the event merge across patients trigger.

Event Detail

Event Id 62768
Product Type Devices
Status Completed
Recalling Firm Sunquest Information Systems, Inc.
City Tucson
State AZ
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-03-15
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Worldwide distribution: USA (nationwide) and countries of: England, United Kingdom and United Arab Emirates.