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.
The agency’s classification
FDA (Devices): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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.
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