Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Terminated

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 Z-2332-2012 · Posted 2012-09-07

Recall StatusTerminated
Product CodeJQP
Date Initiated2012-03-15
Date Terminated2012-10-02
Product Quantity126 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

Firm Action

The firm, Sunquest, sent an "Urgent- Product Safety Notice: PSN-12-02" dated March 15, 2012 to all their customers who purchased the Sunquest Laboratory versions 6.1.0125 through 6.1.0139, 6.2.1, 6.2.2, 7.0, and 7.0.1. The notice described the product, the problems and the actions to be taken. Customers were instructed to request the software correction by creating a Case via the Client Support webpage at: www.sunquestinfo.com/supportweb. Customers with questions were instructed to contact Client support at (877) 239-6337 for US and Canadian Sites and at +44 (0) 161 335 0562 for international sites.

Root Cause

Software design

Distribution Pattern

Worldwide distribution: USA (nationwide) and countries of: England, United Kingdom and United Arab Emirates.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

↑