Sunquest Laboratory SMART Software Recall for Incorrect Patient Data
Sunquest Information Systems is recalling Sunquest Laboratory SMART software versions 6.4.2 due to a defect that may display incorrect patient demographic data.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class III, which indicates the product is not likely to cause adverse health consequences. The hazard is a software defect leading to data errors, which fits the criteria for a moderate severity recall involving minor errors or low-risk issues.
Plain-English summary
Sunquest Information Systems, Inc. is recalling Sunquest Laboratory SMART and Sunquest Laboratory SMART Select software, version 6.4.2. The software is used for clinical purposes and was distributed to 47 sites nationwide.
The recall was initiated because a defect in the graphical user interface (GUI) inquiry function may return incorrect patient demographic data. This error occurs when searching by ID (CID) if the accession number associated with the CID is no longer inactive.
Healthcare facilities using this software should contact Sunquest Information Systems for further instructions on how to resolve the issue.
The recalled product
- Product
- Sunquest Laboratory SMART & Sunquest Laboratory SMART Select Product Usage: for clinical use
- Manufacturer
- Sunquest Information Systems, Inc.
- Hazard
- Affected units
- 47
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Version 6.4.2
Distribution
Distributed nationwide across the United States.
Related recalls
Same manufacturer · Sunquest Information Systems, Inc.
See all →- ModerateSunquest Laboratory Version 7.0 Recalled for Data Integrity Errors
FDA (Devices) · 2012-11-14
- HighSunquest Phlebotomy Interface Software Recall for Inappropriate Order Combination
FDA (Devices) · 2012-11-14
- LowSunquest Laboratory Software Recall for Calculation Errors in Online Entry
FDA (Devices) · 2012-10-24
- ModerateSunquest Laboratory Software Recalled for Patient Data Merge Errors
FDA (Devices) · 2012-09-19
- ModerateSunquest Laboratory Software Recall for Microbiology Data Entry Errors
FDA (Devices) · 2012-09-05
Same hazard · data integrity
See all →- ModerateVentana Recalls navify Digital Pathology Software Due to Image Metadata Discrepancies
FDA (Devices) · 2026-08-19
- SevereGE Healthcare MAC VU360 Electrocardiograph Software Recall
FDA (Devices) · 2026-08-12
- SevereCopan WASPLab Software Recall Over Results Overwrite Issue
FDA (Devices) · 2026-08-12
- SevereMedline spinal anesthesia trays recalled over Huons bupivacaine quality concerns
FDA (Devices) · 2026-06-03
- SevereMedline pain and Whitacre spinal trays recalled over bupivacaine concerns
FDA (Devices) · 2026-06-03