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 - DangerousWhat Should You Do?
- Check if you have this product: Version versions 6.1.0125 through 6.1.0139, 6.2.1, 6.2.2, 7.0, and 7.0.1
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Sunquest Information Systems, Inc.
- 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
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full 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.
Product Codes/Lot Numbers:
Version versions 6.1.0125 through 6.1.0139, 6.2.1, 6.2.2, 7.0, and 7.0.1
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-2332-2012
Related Recalls
Sunquest Laboratory, version 7.0 not available
Sunquest Information Systems
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.
Sunquest Application Interfacing Outbound Phlebotomy Point of Care Interface, v3.0.0_07222004 and later.
Sunquest Information Systems
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.
Sunquest Laboratory : intended for use by professionals working in a clinical laboratory.
Sunquest Information Systems
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.