Device Recall Sunquest Laboratory

Versions 6.4.0 and later

Clinical Chemistry and Clinical Toxicology Devices

1

No

Nationwide distribution

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

Versions 6.4 and later

Clinical Chemistry and Clinical Toxicology Devices

1

No

Worldwide Distribution -- USA (nationwide) and the country of Canada.

Sunquest Laboratory Versions 6.4 and later using Microbiology Result Entry

Version versions 6.1.0125 through 6.1.0139, 6.2.1, 6.2.2, 7.0, and 7.0.1

Clinical Chemistry and Clinical Toxicology Devices

1

No

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

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.